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 .
DETAILED ACTION
Claim Rejections - 35 USC § 112b
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 1 and dependent claims are 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 1 recites “a first housing part that houses the treatment tool pipe line and a second housing part that houses the imager are provided adjacent to each other at a proximal end portion of the first member”. The delineation between the first housing part 711 and the second housing part 712 is unclear. Based on the figures 9-12, where the boundaries of the first housing part and the second housing part start and end is not considered to be shown. For example, elements 711 and 712 are labeled on the front portion of the tip, while in fig 10, they are labeled as a front portion and a rear portion of the tip, although fig 10 contains two instances of reference character 712 which is unclear if this is an error. Figure 11 and 12 also labels the lumens as these elements creating additional ambiguity. It appears the first and second housing parts are halves of cylinders and will be considered as such, but applicant must clearly define these elements in the figures and the description. This issue is not considered resolved based on the amendment as described below.
Claim 1 recites “wherein the second housing part has a shape in which a cylindrical space for housing the imager is connected to a rectangular space for housing a prism, an image sensor and a main substrate”, but this does not appear to be how the device is configured or depicted in the specification and would thus constitute new matter. Specifically, the second housing part 712 as seen in fig 9 is considered to only contain a rectangular space where the imager is housed, while other cylindrical spaces 711 and 713 are for a treatment tool pipe and an incorporated part respectively, i.e. these cylindrical spaces do not house the imager. There appears to be no other viable cylindrical space associated with the second housing part. As such, since the space that houses the imager is rectangular in nature, it is unclear where this newly claimed cylindrical space exists. As such, it will be interpreted as solely as a rectangular space.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 3-5, 8 – 12 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Ishii US20160345806.
Makita discloses for claim 1, based on the provided interpretation above and until resolution of the 112b issues, “An endoscope comprising:
an insertion part (insertion section 2; fig 1; 0049), wherein the insertion part incorporates a treatment tool pipe line (channel hole 25; fig 3; 0068) into which a treatment tool is to be inserted, an imager, and a part of a cable connected to the imager (image pickup section 32 and signal cable 33; fig 13A; 0084-0085), a distal end portion of the insertion part has a tubular first member that houses an incorporated object of the insertion part, a first housing part that houses the treatment tool pipe line and a second housing part that houses the imager are provided adjacent to each other at a proximal end portion of the first member, wherein the second housing part has a shape in which a cylindrical space for housing the imager is connected to a rectangular space for housing a prism, an image sensor and a main substrate (based on the interpretation cited above, fig 15 shows a rectangular observation optical unit 30 space), an opening (third cutout section 20c3; fig 3; 0079) communicating with the second housing part is formed at an outer peripheral surface of the proximal end portion, in a state of being viewed in an axial direction of the insertion part, the outer peripheral surface of the proximal end portion includes a first region where a distance from a center of the insertion part is a first distance, and a second region where another distance is a second distance that is larger than the first distance, in a state of being viewed in the axial direction, the second region and the opening are disposed on opposite sides with the center of the insertion part interposed therebetween, and the first housing part is disposed adjacent to the second region (based on the interpretation provided above: figs 3 shows two adjacent regions, one containing an instrument channel and the other containing an imager as the incorporated object, i.e. the instrument channel 25 and the section of the housing which contains the imager as the incorporated object, having different distances from the center axis; 0064 describes the first retaining hole 21 as containing the observation optical unit 30)”.
Makita discloses for claim 3, “The endoscope according to claim 1, wherein the first housing part and the second housing part communicate with each other (fig 3 shows two sections of the housing containing the tool channel and incorporated objects as communicating with each other)”.
Makita discloses for claim 4, “The endoscope according to claim 3, wherein a third housing part that houses the incorporated object is provided at the proximal end portion, and the second housing part and the third housing part communicate with each other (e.g. fig 3; 20c1 as the third housing portion on a proximal end portion communicating with a second housing part)”.
Makita discloses for claim 5, “The endoscope according to claim 4, wherein the incorporated object housed in the third housing part is a light guide (fig 3, 15; the proximal portion of the housing which contains the illumination optical unit 40A or 40B)”.
Ishii discloses for claim 8, “The endoscope according to claim 1, wherein a fourth housing part that houses a fluid pipe line to a distal end of which a nozzle is fixed, as the incorporated object, is provided at the proximal end portion, the distal end portion of the insertion part has a second member fixed to an outer peripheral surface of the first member on a distal end side of the first member, in a state of being viewed in the axial direction, the outer peripheral surface of the first member that is fixed to the second member includes a third region where a distance from the center of the insertion part is a third distance, and a fourth region where the distance is a fourth distance that is larger than the third distance, and the fourth region is provided along an outer peripheral edge of the fourth housing part (fig 15 shows the relationship between the nozzle channel 22 and the other elements, considered to read on the claim based on the interpretation provided above).
Ishii discloses for claim 9, “The endoscope according to claim 1, wherein the insertion part includes a bendable portion (fig 1; 0049 describes the bending section) that has a fixing member fixed to the outer peripheral surface of the proximal end portion, at a distal end of the bendable portion, and the fixing member covers the opening and has an opening portion that exposes the second region (distal end bending die 51 which sheaths the opening; fig 2)”.
For claims 10-12, additional prior art could not be identified and applied due to indefiniteness and therefore, patentability will be reevaluated upon resolution of the indefiniteness.
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.
Claim(s) 2, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishii as applied to claim 1 above, and further in view of Truckai US20180160893.
Ishii does not disclose for claim 2, “The endoscope according to claim 1, wherein a ratio of an inner diameter of the treatment tool pipe line to an outer diameter of a distal end portion of the insertion part is 35% or more, and the inner diameter is 3 mm or more”.
Truckai teaches an endoscope comprising: an insertion part (shaft 110; fig 1; 0037), wherein the insertion part incorporates a treatment tool pipe line (working channel 145; fig 3; 0037) into which a treatment tool is to be inserted, and a ratio of an inner diameter of the treatment tool pipe line to an outer diameter of a distal end portion of the insertion part is 35% or more (0008 describes multiple configuration of ratios from 30%-70%), and the inner diameter is 3 mm or more (0037 describes the diameter of the channel as 1 – 6 mm). Since Ishii fails to disclose the nature of the measurements, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any suitable measurements known in the art, including the one taught by Truckai to achieve the predictable result of providing a viable endoscope for insertion into a subject.
Modified Ishii discloses for claim 14, “The endoscope according to claim 2, wherein the outer diameter of the distal end portion is 7.6 mm or more and 8.5 mm or less (Truckai: 0036 describes the shaft diameter as 2.5 – 10 mm)”.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishii as applied to claim 1 above, and further in view of Vazales US20170258550.
Ishii does not disclose for claim 6, “The endoscope according to claim 1, wherein a fourth housing part that houses the incorporated object is provided at the proximal end portion, and a proximal end side of the fourth housing part has an oval cross section perpendicular to the axial direction”. Vazales teaches in the same field of endeavor, visualization tube cross section can be circular, oval, or elliptical (0096). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Vazales into the invention of Ishii in order to configure the endoscope e.g. as claimed because it allows accommodating different shaped tools.
Modified Ishii discloses for claim 7, “The endoscope according to claim 6, wherein the incorporated object housed in the fourth housing part is a fluid pipe line (Ishii: 0081 discloses a fluid line with a nozzle)”.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishii as applied to claim 1 above, and further in view of Iizuka US20160367114.
Ishii does not disclose for claim 13, “The endoscope according to claim 1, wherein the second housing part houses the imager, and a rear surface of an imaging element included in the imager is disposed to face a radial outer side of the distal end portion”. Iizuka teaches in the same field of endeavor, providing an endoscope with a side viewing imager (fig 1, 2; 0017). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Iizuka into the invention of Ishii in order to configure the endoscope e.g. as claimed because it provides an endoscope better suited for side viewing, such as the walls of lumens.
Response to Arguments
Applicant's arguments filed 3/20/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the rejection of claim 1 citing Ishii is deemed not persuasive because the scope of the recited first region and second region are broad enough to configure the first and second distances as any distance confined to the radius of the insertion section. In other words, the claim requires the outer peripheral surface which is interpreted as the circumference includes a “first region”, where the first region is interpreted as a sector of the circle which includes the circumference arc as viewed in the axial direction. The second region is also a sector of the circle and since the first and second regions can be and is interpreted as sectors of the circle, the distances in question can be any measure of the radius since the regions are sectors of the circle and not solely the circumferences, therefore the second distance can be interpreted to be larger than the first distance.
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 JAE K WOO whose telephone number is (571)272-0837. The examiner can normally be reached M-F 8:30-2:30p, 6p-9p.
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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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/Jae Woo/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
5/16/26
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