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 .
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.
Claims 1-15, and 17, and 19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Busch et al (Patent Application Publication DE102020133405A1, hereinafter “Busch”). In regards to claim 1, Busch teaches an endoscope (figure 1 element 2) comprising:
a handle (figure 2 element 6) or interface
an insertion cord (Figure 1 element 12) extending from the endoscope handle or interface and configured to be inserted into a patient’s body cavity
the handle or interface comprising a Y-connector (figure 3 element 100) including: a first branch (figure 3 element 108 pointed two by the right arrow below) or socket having a first opening (figure 3 element 112) from which a first channel extends
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a second branch (figure 3 element 106 pointed to by the left arrow above) or socket having a second opening (figure 3 element 110) from which a second channel extends
a third branch (figure 3 region circled below) or socket having a third opening (figure 7 region circled below), wherein the first channel and the second channel join each other in a third joined channel (figure 3 circled below) that extends inside the third branch or socket towards the third opening (figure 3 pointed to below)
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wherein the first channel and a first portion of the third joined channel form together an instrument insertion channel of the Y-connector (figure 3 area circled below) Paragraph 10 of Busch states that channel 106 is a “biopsy channel”, and therefore teaches the instrument insertion channel of the claimed invention.
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the second channel and a second portion of the third joined channel form together a suction channel of the Y-connector (figure 3 area circled below). Channel 106 is labelled as a working channel, and in paragraph 5 of the specification Busch states “usually the working channel is also used for a suction/vacuum function in order to suck fluid and/or tissue…”
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a working channel tube is directly or indirectly connected to the third joined channel and extends from the endoscope handle or interface into the insertion cord (figure 1 seen below, y-connector 100 extends into insertion cord 12)
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the instrument insertion channel and the suction channel are at least in portions displaced or offset with respect to each other. (figure 3 elements 108 and 106 are separated at the proximal ends)
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In regards to claim 2, Busch teaches an endoscope wherein:
the suction channel is a straight channel and has a suction channel central axis (paragraph 78 “all three straight moulding cores C1, C2, and C3 have a rotationally symmetric shape along a straight central axis”)
a proximal working channel tube portion of the working channel tube is directly or indirectly connected to the third joined channel (figure 3 pointed to by the left arrow above)
the proximal working channel tube portion comprising a proximal working channel tube portion central axis; the suction channel central axis is parallel to the proximal working channel tube portion central axis and the suction channel forms a continuation of the proximal working channel tube portion (working channel and suction channel are the same and are therefore parallel)
the suction channel central axis corresponds to the proximal working channel tube portion central axis (working channel and suction channel axes are the same)
a cross-sectional area of the suction channel increases in the second channel towards the second opening (paragraph 79 “the first straight moulding core C1 has a shape of three coaxially aligned cylinders with three different diameters, the diameters of the cylinders decreasing towards the centre respectively the bottom half central portion” as seen in figure 11 below)
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In regards to claim 3, Busch teaches an endoscope wherein:
the suction channel is a straight channel and has a suction channel central axis (paragraph 78 “all three straight moulding cores C1, C2, and C3 have a rotationally symmetric shape along a straight central axis”)
a proximal working channel tube portion of the working channel tube is directly or indirectly connected to the third joined channel (figure 3 the area circled below)
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the proximal working channel tube portion comprising a proximal working channel tube portion central axis (fig 3 axis L1 above)
the suction channel central axis is parallel to the proximal working channel tube portion central axis and the suction channel forms a continuation of the proximal working channel tube portion (the suction and working channels are one and the same)
In regards to claim 4, Busch teaches an endoscope wherein the suction channel central axis corresponds to the proximal working channel tube portion central axis (the suction and working channels are one and the same)
In regards to claim 5, Busch teaches an endoscope wherein a cross-sectional area of the suction channel increases in the second channel towards the second opening (paragraph 79 “the first straight moulding core C1 has a shape of three coaxially aligned cylinders with three different diameters, the diameters of the cylinders decreasing towards the centre respectively the bottom half central portion” In regards to claim 6, Busch teaches an endoscope wherein the instrument insertion channel is a curved channel and has a curved instrument insertion channel central axis (figure 3 axis L2), wherein the curved instrument insertion channel central axis lies in or defines a first plane, and wherein a suction channel central axis does not lie in the first plane (suction channel axis is displaced from instrument insertion channel axis as seen below).
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In regards to claim 7, Busch teaches an endoscope wherein the suction channel central axis is parallel to the first plane or crosses the first plane at an intersection point (see intersection point circled above).
In regards to claim 8, Busch teaches an endoscope wherein the first channel is a curved channel having a curvature at least in sections inside the first branch (figure 3 curve circled below) or socket and/or the first portion of the third joined channel is or forms a curved channel having a curvature at least in sections inside the third branch or socket.
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In regards to claim 9, Busch teaches an endoscope wherein the instrument insertion channel is a curved channel and has a curved instrument insertion channel central axis (figure 3 curve circled above), wherein the curved instrument insertion channel central axis lies in or defines a first plane, and wherein a suction channel central axis does not lie in the first plane (suction channel axis is displaced from instrument insertion channel axis as seen above by the two arrows), wherein the curved instrument insertion channel central axis lies completely in the first plane (the curved instrument insertion channel central axis defines the first plane, and so lies completely within it), and wherein the suction channel central axis is parallel to the first plane or crosses the first plane at an intersection point (see intersection point two images above).
In regards to claim 10, Busch teaches an endoscope wherein the first channel is a curved channel having a curvature at least in sections inside the first branch (figure 3 curve circled above) or socket and/or the first portion of the third joined channel is or forms a curved channel having a curvature at least in sections inside the third branch or socket, wherein a suction channel central axis and an instrument insertion channel central axis or line are displaced or offset with respect to a center point or central axis of the third opening (both combine to create the third opening, so the center point of the third opening is a point in between both central axes), and wherein the first channel is formed to be configured to pre-bend an instrument inserted into the instrument insertion channel inside the first branch or socket through its curvature (channel is curved, and a straight, flexible instrument would be “pre-bent” by said curve as it enters the channel).
In regards to claim 11, Busch teaches an endoscope wherein the instrument insertion channel and the suction channel merge inside the third branch or socket and form a cross-section in the shape of connected circles inside the third branch or socket, and wherein the third opening has a shape of connected circles (see figure 2 (left) of claimed invention and figure 7 (right) of reference below, both channel orientations create an opening in the shape of connected circles of the combined suction and instrument insertion channels).
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In regards to claim 12, Busch teaches an endoscope wherein the first channel is a curved channel having a curvature at least in sections inside the first branch (figure 3 curve circled below) or socket and/or the first portion of the third joined channel is or forms a curved channel having a curvature at least in sections inside the third branch or socket.
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In regards to claim 13, Busch teaches an endoscope wherein the instrument insertion channel and the suction channel merge inside the third branch or socket and form a cross-section in the shape of connected circles inside the third branch or socket (see figure 2 of claimed invention and figure 7 of reference two images above, both channel orientations create an opening in the shape of connected circles of the combined suction and instrument insertion channels).
In regards to claim 14, Busch teaches an endoscope wherein the third opening has a shape of connected circles (see figure 2 of claimed invention and figure 7 of reference above, both channel orientations create an opening in the shape of connected circles of the combined suction and instrument insertion channels).
In regards to claim 15, Busch teaches an endoscope wherein the first channel is a curved channel having a curvature at least in sections inside the first branch (figure 3 curve circled below) or socket and/or the first portion of the third joined channel is or forms a curved channel having a curvature at least in sections inside the third branch or socket, wherein the instrument insertion channel and the suction channel merge inside the third branch or socket and form a cross-section in the shape of connected circles inside the third branch or socket (see figure 2 of claimed invention and figure 7 of reference two images above, both channel orientations create an opening in the shape of connected circles of the combined suction and instrument insertion channels) wherein the third opening has a shape of connected circles (see figure 2 of claimed invention and figure 7 of reference two images above, both channel orientations create an opening in the shape of connected circles of the combined suction and instrument insertion channels), and wherein a suction channel central axis and an instrument insertion channel central axis or line are displaced or offset with respect to a center point or central axis of the third opening (both combine to create the third opening, so the center point of the third opening is a point in between both central axes).
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In regards to claim 17, Busch teaches an endoscope wherein the first channel is formed to be configured to pre-bend an instrument inserted into the instrument insertion channel inside the first branch or socket through its curvature (channel is curved, and a straight, flexible instrument would be “pre-bent” by said curve as it enters the channel).
In regards to claim 19, Busch teaches a visualization system comprising: an endoscope and a monitor connectable to the endoscope (paragraph 2 “the present disclosure relates to… a system comprising the endoscope and a monitor” and paragraph 58 “such that the patient’s body cavity can be illuminated and inspected and can be viewed via the monitor M”).
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.
Claim 16 is rejected 35 U.S.C. 103 as being unpatentable over Busch. In regards to claim 16, Busch teaches an endoscope wherein a diameter or circumference of the suction channel is smaller than a diameter or circumference of the instrument insertion channel. Busch fails to explicitly disclose wherein the diameter of the suction channel is smaller than that of the diameter of the instrument insertion channel.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the diameter of the suction channel of Busch smaller than that of the instrument insertion channel since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the suction channel would not operate differently with the claimed smaller diameter than that of the instrument insertion channel. Further, Applicant places no criticality on the range claimed, indicating that, in paragraph 38 of the specification, ”preferably, a cross-section, in particular a diameter or circumference, of the suction channel may be smaller than a cross-section, in particular a diameter or circumference, of the instrument insertion channel.” The specification does not impart criticality upon the relative dimensions of the suction and instrument insertion channels due to the limitation being something that “may” be included, meaning that a different relative relationship would also perform the intended function.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Busch in view of Kunuki (U.S. Patent Application 2023/0320575). While Busch teaches the limitation of claims 1 and 12, it fails to teach an endoscope wherein the Y-connector is manufactured as an integral plastic piece. Kunuki teaches an endoscope wherein the Y-connector is manufactured as an integral plastic piece (paragraph 60 ”the branching member 50 is configured such that the body part 53 and the connecting member 60 are separate bodies, but these may be integrally molded”). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the Y-connector of Busch to be manufactured as a single piece in order to save in manufacturing costs, as integral molding eliminates the need for assembly of multiple component pieces.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAYTON BARKER whose telephone number is (571)272-0912. The examiner can normally be reached between 9:00 and 5:00 PM EST.
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/DAYTON HYUN JIN BARKER/Patent Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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