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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/25/2025 has been entered.
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.
Claims 1-18 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 the limitation “a surface of a vertical arm (3212) is provided with a clip opening (32121)” which renders the claim unclear. It is unclear whether “a vertical arm” is the same “vertical arm” mentioned earlier in claim 1.
Claim 10 recites the limitation “a surface of a vertical arm (3212) is provided with a clip opening (32121)” which renders the claim unclear. It is unclear whether “a vertical arm” is the same “vertical arm” mentioned earlier in claim 1.
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.
Claims 1-2, & 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Sasady et al (US20060241477A1; hereinafter referred to as Sasady) in view of Shikata (US20150335350A1)
Regarding Claim 1, Sasady discloses a needle support structure ("A needle guide supporting device with clips means 2 for detachable fastening to an ultrasound head 3" [Abstract]), comprising:
a first needle inlet plate (needle guide supporting device 1) ("The needle guide supporting device 1 shown in FIG. 1 is provided with clip means 2 for fastening to an ultrasound head 3 shaped as a circular arc" [0017], see Fig 1),
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a second needle inlet plate (wedge-shaped needle guide 5) and a locking device (a rotatable handle 4 + projecting pin 5a) ("A wedge-shaped needle guide 5 can then be inserted in a corresponding wedge-shaped recess 1c in the device. The rotatable handle 4 is then rotated into a second position, thereby fixing the wedge-shaped needle guide 5 due to a projecting pin 5 a on the needle guide 5 " [0017]),
wherein a first plate surface of the first needle inlet plate is a needle inlet wall (wedge-shaped recess 1c) ("A wedge-shaped needle guide 5 can then be inserted in a corresponding wedge-shaped recess 1c in the device. " [0017]);
wherein a first plate surface of the second needle inlet plate is provided with a plurality of semi-open needle inlet channels (grooves 5b) ("The inner side of the needle guide 5 is provided with a plurality of grooves 5b," [0019], Fig 4. [0019]),
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and the needle inlet wall is fitted to the first plate surface of the second needle inlet plate to form closed needle channels (See Fig 5. for the mating of needle inlet wall and second needle inlet plate to create closed needle channels 7);
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characterized in that the locking device comprises a first clamping part (rotatable handle 4) and a second clamping part (projecting pin 5a) ("a rotatable handle 4 for fixing a needle guide 5…the rotatable handle 4 is then rotated into a second position, thereby fixing the wedge-shaped needle guide 5 due to a projecting pin 5a" [0017], see Fig. 1),
wherein the first clamping part comprises a rocker (rotatable handle 4), which comprises a rocking arm (projecting grip 4c), and a first end of the rocking arm is rotatably connected to the first needle inlet plate ("The needle guide supporting device 1 shown in FIG. 1 is provided with clip means 2 for fastening to an ultrasound head 3 shaped as a circular arc as well as a rotatable handle 4 for fixing a needle guide 5." [0017]),
and the second clamping part is fixedly connected to the second needle inlet plate; alternatively, the first clamping part is rotatably connected to the second needle inlet plate, (“The needle guide supporting device 1 shown in FIG. 1 is provided with clip means 2 for fastening to a an ultrasound head 3 shaped as a circular arc as well as a rotatable handle 4 for fixing a needle guide 5…The rotatable handle 4 is then rotated into a second position, thereby fixing the wedge-shaped needle guide 5 due to a projecting pin 5 a on the needle guide 5” [0017]);
a first side end of the rocking arm is provided with a protruding positioning block (projecting spring pre-stresssed ball in the handle 4); the second clamping-part comprises a buckle plate (needle guide 5), which is arranged on a first side end of the second needle inlet plate, is perpendicular to a plane in which the second needle inlet plate is located, and the buckle plate is provided with a positioning hole (recess 9); when the protruding positioning block is in a first position, the protruding positioning block and the buckle plate are located on a same side of the first needle inlet plate and the second needle inlet plate, and the protruding positioning block is clamped into the positioning hole;
Sasady does not specifically disclose the first clamping part further comprises a slider, which comprises a slider arm; a vertical arm vertically arranged on a first plate surface of the slider arm; the second clamping part further comprises a lock-block, which is arranged on a second side end of the second needle inlet plate, and which is located in the plane in which the second needle inlet plate is located; a surface of a vertical arm is provided with a clip opening, the needle inlet wall is fitted to the first plate surface of the second needle inlet plate, and when the vertical arm moves to the first position, the clip opening is clamped onto the lock-block; wherein the first clamping part can move between a first clamping part position and a second clamping part position, thereby enabling two snap-on connections between the first clamping part and the second clamping part, the two snap-on connections each comprises: in the first position, the positioning block on the first side end of the rocking arm is clamped into the positioning hole of the buckle plate; with the clip opening of the vertical arm is clamped onto the lock-block; in the second position, the positioning block is disengaged from the positioning hole, and the clip opening of the vertical arm is disengaged from the lock-block , so that the first needle inlet plate and the second needle inlet plate are separated by translating in a direction perpendicular to an insertion direction of a puncture needle.
However, in a similar field of endeavor, Shikata teaches A puncture adapter according to the embodiment includes a first pressing part that has a first surface and a second surface serving as a surface opposite to the first surface; a second pressing part that has a third surface; a fixing part that fixes [Abstract].
Shikata also teaches that the first clamping part further comprises a slider, which comprises a slider arm; a vertical arm vertically arranged on a first plate surface of the slider arm (“The following describes the structure of the fixing part 490 with reference to FIGS. 15A and 15B. FIGS. 15A and 15B are perspective views of the fixing part 490 according to the modification of the second embodiment. As illustrated in FIGS. 15A and 15B, the fixing part 490 has the first hinge 491, a second hinge 492, and a coupling area 493 each of which is foldable.” [0122]);
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the second clamping part further comprises a lock-block, which is arranged on a second side end of the second needle inlet plate, and which is located in the plane in which the second needle inlet plate is located; a surface of a vertical arm is provided with a clip opening, the needle inlet wall is fitted to the first plate surface of the second needle inlet plate, and when the vertical arm moves to the first position, the clip opening is clamped onto the lock-block (“The following describes the engagement state in the through hole 475 with reference to FIG. 16. FIG. 16 is a view for explaining the engagement state in the through hole 475 according to the modification of the second embodiment. FIG. 16 is a top view of the adapter 460 viewed from the gripper 12 side. As illustrated in FIG. 16, the connection 461 of the pressing part 480 is inserted into the through hole 475 formed in the guide part 470, thereby engaging with the through hole 475.” [0125], “the first hinge 491 of the fixing part 490 is inserted into the through hole 475 with the second area 461 b engaging with the guide part 470. Thus, the first hinge 491 engages with the connection 461. More specifically, the first hinge 491 inserted into the through hole 475 engages with the second area 461 b at B illustrated in FIG. 16. The first hinge 491 engages with the second area 461 b with the second area 461 b engaging with the guide part 470, whereby the guide part 470, the pressing part 480, and the fixing part 490 are fixed and integrated.” [0126])
wherein the first clamping part can move between a first clamping part position and a second clamping part position, thereby enabling two snap-on connections between the first clamping part and the second clamping part (“The first area 461 a of the connection 461 is bent, thereby bringing the second surface 480 b of the pressing part 480 into contact with the surface 470 a of the guide part 470. In this state, the coupling area 493 is bent, whereby the second hinge 492 sandwiches the guide part 470 and the pressing part 480. The pressing part 480 fits into the recess 18 on the first surface 16 of the cutout portion 15, and the guide part 470 fits into the recess 19 of the cutout portion 15. Subsequently, the second hinge 492 is fastened to the first surface 16 of the cutout portion 15 with the guide part 470 and the pressing part 480 sandwiched therebetween.” [0127],
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the two snap-on connections each comprises: in the first position, the positioning block on the first side end of the rocking arm is clamped into the positioning hole of the buckle plate; with the clip opening of the vertical arm is clamped onto the lock-block; in the second position, the positioning block is disengaged from the positioning hole, and the clip opening of the vertical arm is disengaged from the lock-block , so that the first needle inlet plate and the second needle inlet plate are separated by translating in a direction perpendicular to an insertion direction of a puncture needle (“The following describes the engagement state in the through hole 475 with reference to FIG. 16. FIG. 16 is a view for explaining the engagement state in the through hole 475 according to the modification of the second embodiment. FIG. 16 is a top view of the adapter 460 viewed from the gripper 12 side. As illustrated in FIG. 16, the connection 461 of the pressing part 480 is inserted into the through hole 475 formed in the guide part 470, thereby engaging with the through hole 475.” [0125], “the first hinge 491 of the fixing part 490 is inserted into the through hole 475 with the second area 461 b engaging with the guide part 470. Thus, the first hinge 491 engages with the connection 461. More specifically, the first hinge 491 inserted into the through hole 475 engages with the second area 461 b at B illustrated in FIG. 16. The first hinge 491 engages with the second area 461 b with the second area 461 b engaging with the guide part 470, whereby the guide part 470, the pressing part 480, and the fixing part 490 are fixed and integrated.” [0126], “The first area 461 a of the connection 461 is bent, thereby bringing the second surface 480 b of the pressing part 480 into contact with the surface 470 a of the guide part 470. In this state, the coupling area 493 is bent, whereby the second hinge 492 sandwiches the guide part 470 and the pressing part 480. The pressing part 480 fits into the recess 18 on the first surface 16 of the cutout portion 15, and the guide part 470 fits into the recess 19 of the cutout portion 15. Subsequently, the second hinge 492 is fastened to the first surface 16 of the cutout portion 15 with the guide part 470 and the pressing part 480 sandwiched therebetween.” [0127], “FIG. 11D is another perspective view of a state where the fixing part 90 is inserted into the guide part 70 according to the second embodiment. “ [0102].
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Sasady as outlined above with the first clamping part further comprises a slider, which comprises a slider arm; a vertical arm vertically arranged on a first plate surface of the slider arm; the second clamping part further comprises a lock-block, which is arranged on a second side end of the second needle inlet plate, and which is located in the plane in which the second needle inlet plate is located; a surface of a vertical arm is provided with a clip opening, the needle inlet wall is fitted to the first plate surface of the second needle inlet plate, and when the vertical arm moves to the first position, the clip opening is clamped onto the lock-block; wherein the first clamping part can move between a first clamping part position and a second clamping part position, thereby enabling two snap-on connections between the first clamping part and the second clamping part, the two snap-on connections each comprises: in the first position, the positioning block on the first side end of the rocking arm is clamped into the positioning hole of the buckle plate; with the clip opening of the vertical arm is clamped onto the lock-block; in the second position, the positioning block is disengaged from the positioning hole, and the clip opening of the vertical arm is disengaged from the lock-block , so that the first needle inlet plate and the second needle inlet plate are separated by translating in a direction perpendicular to an insertion direction of a puncture needle as taught by Shikata, because this can reduce the time for sterilization, thereby improving the throughput of an examination [0084].
Regarding Claim 2, Sasady discloses that the first needle inlet plate and the second needle inlet plate are sector-shaped plates, comprising an arc-shaped end and a circle center end (See Fig. 1 for arc shaped and circle center end);
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wherein first ends of the plurality of semi-open needle inlet channels are needle introduction ports, which are arranged at the arc-shaped end of the second needle inlet plate, and second ends of the plurality of semi-open needle inlet channels are communicated to form a needle release port, which is arranged at the circle center end of the second needle inlet plate (See Fig. 3 for needle release port at circle center of the second needle inlet plate).
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Regarding Claim 10, Sasady discloses a needle support structure ("A needle guide supporting device with clips means 2 for detachable fastening to an ultrasound head 3" [Abstract]), comprising:
a first needle inlet plate (needle guide supporting device 1) ("The needle guide supporting device 1 shown in FIG. 1 is provided with clip means 2 for fastening to an ultrasound head 3 shaped as a circular arc" [0017], see Fig 1),
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a second needle inlet plate (wedge-shaped needle guide 5) and a locking device (a rotatable handle 4 + projecting pin 5a) ("A wedge-shaped needle guide 5 can then be inserted in a corresponding wedge-shaped recess 1c in the device. The rotatable handle 4 is then rotated into a second position, thereby fixing the wedge-shaped needle guide 5 due to a projecting pin 5 a on the needle guide 5 " [0017]),
wherein a first plate surface of the first needle inlet plate is a needle inlet wall (wedge-shaped recess 1c) ("A wedge-shaped needle guide 5 can then be inserted in a corresponding wedge-shaped recess 1c in the device. " [0017]);
wherein a first plate surface of the second needle inlet plate is provided with a plurality of semi-open needle inlet channels (grooves 5b) ("The inner side of the needle guide 5 is provided with a plurality of grooves 5b," [0019], Fig 4. [0019]),
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and the needle inlet wall is fitted to the first plate surface of the second needle inlet plate to form closed needle channels (See Fig 5. for the mating of needle inlet wall and second needle inlet plate to create closed needle channels 7);
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characterized in that the locking device comprises a first clamping part (rotatable handle 4) and a second clamping part (projecting pin 5a) ("a rotatable handle 4 for fixing a needle guide 5…the rotatable handle 4 is then rotated into a second position, thereby fixing the wedge-shaped needle guide 5 due to a projecting pin 5a" [0017], see Fig. 1),
wherein the first clamping part comprises a rocker (rotatable handle 4), which comprises a rocking arm (projecting grip 4c), and a first end of the rocking arm is rotatably connected to the first needle inlet plate ("The needle guide supporting device 1 shown in FIG. 1 is provided with clip means 2 for fastening to an ultrasound head 3 shaped as a circular arc as well as a rotatable handle 4 for fixing a needle guide 5." [0017]),
and the second clamping part is fixedly connected to the second needle inlet plate; alternatively, the first clamping part is rotatably connected to the second needle inlet plate, (“The needle guide supporting device 1 shown in FIG. 1 is provided with clip means 2 for fastening to a an ultrasound head 3 shaped as a circular arc as well as a rotatable handle 4 for fixing a needle guide 5…The rotatable handle 4 is then rotated into a second position, thereby fixing the wedge-shaped needle guide 5 due to a projecting pin 5 a on the needle guide 5” [0017]);
a first side end of the rocking arm is provided with a protruding positioning block (projecting spring pre-stresssed ball in the handle 4); the second clamping-part comprises a buckle plate (needle guide 5), which is arranged on a first side end of the second needle inlet plate, is perpendicular to a plane in which the second needle inlet plate is located, and the buckle plate is provided with a positioning hole (recess 9); when the protruding positioning block is in a first position, the protruding positioning block and the buckle plate are located on a same side of the first needle inlet plate and the second needle inlet plate, and the protruding positioning block is clamped into the positioning hole;
wherein the first clamping part can move between a first clamping part position and a second clamping part position, thereby enabling two snap-on connections between the first clamping part and the second clamping part. (" The rotatable handle 4 is then rotated into a second position, thereby fixing the wedge-shaped needle guide 5 due to a projecting pin 5 a on the needle guide 5 and the folding 4 a at the bottom of the handle 4, said folding engaging the pin 5 a—cf. FIG. 2. When the handle is in this position, a needle 7 can penetrate the needle guide 5. " [0017], “This will only be possible until the handle 4 is rotated all the way into a subsequent position. The rotatable handle 4, being rotatable about the centre of rotation 4 b, is fixated in each of the aforementioned positions by means of a projecting spring pre-stressed ball in the handle 4, which can be inserted in corresponding recesses 9 in the device. The rotatable handle 4 is provided with a projecting grip 4 c facilitating operation thereof.” [0018], Sasady requires 2 snap connections to lock in the clamping parts one connection is between projecting spring pre-stressed ball in the handle 4, which can be inserted in corresponding recesses 9 and the second connection is projecting pin 5 a on the needle guide 5 and the folding 4a at the bottom of rotatbable handle 4 ).
Sasady does not specifically disclose a needle guide bracket, that the first clamping part further comprises a slider, which comprises a slider arm; a vertical arm vertically arranged on a first plate surface of the slider arm; the second clamping part further comprises a lock-block, which is arranged on a second side end of the second needle inlet plate, and which is located in the plane in which the second needle inlet plate is located; a surface of a vertical arm is provided with a clip opening, the needle inlet wall is fitted to the first plate surface of the second needle inlet plate, and when the vertical arm moves to the first position, the clip opening is clamped onto the lock-block; wherein the first clamping part can move between a first clamping part position and a second clamping part position, thereby enabling two snap-on connections between the first clamping part and the second clamping part, the two snap-on connections each comprises: in the first position, the positioning block on the first side end of the rocking arm is clamped into the positioning hole of the buckle plate; with the clip opening of the vertical arm is clamped onto the lock-block; in the second position, the positioning block is disengaged from the positioning hole, and the clip opening of the vertical arm is disengaged from the lock-block , so that the first needle inlet plate and the second needle inlet plate are separated by translating in a direction perpendicular to an insertion direction of a puncture needle.
However, in a similar field of endeavor, Shikata teaches A puncture adapter according to the embodiment includes a first pressing part that has a first surface and a second surface serving as a surface opposite to the first surface; a second pressing part that has a third surface; a fixing part that fixes [Abstract].
Shikata also teaches a needle guide bracket (“As illustrated in FIGS. 14A and 14B, a plurality of guide grooves 471 a, 471 b, 471 c, and 471 d that guide the puncture needle are formed on a surface (also referred to as a third surface) 470 a of the guide part 470 coming into contact with one surface of the pressing part 480. Because the guide grooves are formed at respective positions and in respective directions, it is possible to perform a puncture on a wider area on an ultrasound image.” [0118])
the first clamping part further comprises a slider, which comprises a slider arm; a vertical arm vertically arranged on a first plate surface of the slider arm (“The following describes the structure of the fixing part 490 with reference to FIGS. 15A and 15B. FIGS. 15A and 15B are perspective views of the fixing part 490 according to the modification of the second embodiment. As illustrated in FIGS. 15A and 15B, the fixing part 490 has the first hinge 491, a second hinge 492, and a coupling area 493 each of which is foldable.” [0122]);
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the second clamping part further comprises a lock-block, which is arranged on a second side end of the second needle inlet plate, and which is located in the plane in which the second needle inlet plate is located; a surface of a vertical arm is provided with a clip opening, the needle inlet wall is fitted to the first plate surface of the second needle inlet plate, and when the vertical arm moves to the first position, the clip opening is clamped onto the lock-block (“The following describes the engagement state in the through hole 475 with reference to FIG. 16. FIG. 16 is a view for explaining the engagement state in the through hole 475 according to the modification of the second embodiment. FIG. 16 is a top view of the adapter 460 viewed from the gripper 12 side. As illustrated in FIG. 16, the connection 461 of the pressing part 480 is inserted into the through hole 475 formed in the guide part 470, thereby engaging with the through hole 475.” [0125], “the first hinge 491 of the fixing part 490 is inserted into the through hole 475 with the second area 461 b engaging with the guide part 470. Thus, the first hinge 491 engages with the connection 461. More specifically, the first hinge 491 inserted into the through hole 475 engages with the second area 461 b at B illustrated in FIG. 16. The first hinge 491 engages with the second area 461 b with the second area 461 b engaging with the guide part 470, whereby the guide part 470, the pressing part 480, and the fixing part 490 are fixed and integrated.” [0126])
wherein the first clamping part can move between a first clamping part position and a second clamping part position, thereby enabling two snap-on connections between the first clamping part and the second clamping part (“The first area 461 a of the connection 461 is bent, thereby bringing the second surface 480 b of the pressing part 480 into contact with the surface 470 a of the guide part 470. In this state, the coupling area 493 is bent, whereby the second hinge 492 sandwiches the guide part 470 and the pressing part 480. The pressing part 480 fits into the recess 18 on the first surface 16 of the cutout portion 15, and the guide part 470 fits into the recess 19 of the cutout portion 15. Subsequently, the second hinge 492 is fastened to the first surface 16 of the cutout portion 15 with the guide part 470 and the pressing part 480 sandwiched therebetween.” [0127],
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the two snap-on connections each comprises: in the first position, the positioning block on the first side end of the rocking arm is clamped into the positioning hole of the buckle plate; with the clip opening of the vertical arm is clamped onto the lock-block; in the second position, the positioning block is disengaged from the positioning hole, and the clip opening of the vertical arm is disengaged from the lock-block , so that the first needle inlet plate and the second needle inlet plate are separated by translating in a direction perpendicular to an insertion direction of a puncture needle (“The following describes the engagement state in the through hole 475 with reference to FIG. 16. FIG. 16 is a view for explaining the engagement state in the through hole 475 according to the modification of the second embodiment. FIG. 16 is a top view of the adapter 460 viewed from the gripper 12 side. As illustrated in FIG. 16, the connection 461 of the pressing part 480 is inserted into the through hole 475 formed in the guide part 470, thereby engaging with the through hole 475.” [0125], “the first hinge 491 of the fixing part 490 is inserted into the through hole 475 with the second area 461 b engaging with the guide part 470. Thus, the first hinge 491 engages with the connection 461. More specifically, the first hinge 491 inserted into the through hole 475 engages with the second area 461 b at B illustrated in FIG. 16. The first hinge 491 engages with the second area 461 b with the second area 461 b engaging with the guide part 470, whereby the guide part 470, the pressing part 480, and the fixing part 490 are fixed and integrated.” [0126], “The first area 461 a of the connection 461 is bent, thereby bringing the second surface 480 b of the pressing part 480 into contact with the surface 470 a of the guide part 470. In this state, the coupling area 493 is bent, whereby the second hinge 492 sandwiches the guide part 470 and the pressing part 480. The pressing part 480 fits into the recess 18 on the first surface 16 of the cutout portion 15, and the guide part 470 fits into the recess 19 of the cutout portion 15. Subsequently, the second hinge 492 is fastened to the first surface 16 of the cutout portion 15 with the guide part 470 and the pressing part 480 sandwiched therebetween.” [0127], “FIG. 11D is another perspective view of a state where the fixing part 90 is inserted into the guide part 70 according to the second embodiment. “ [0102].
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Sasady as outlined above with a needle guide bracket; the first clamping part further comprises a slider, which comprises a slider arm; a vertical arm vertically arranged on a first plate surface of the slider arm; the second clamping part further comprises a lock-block, which is arranged on a second side end of the second needle inlet plate, and which is located in the plane in which the second needle inlet plate is located; a surface of a vertical arm is provided with a clip opening, the needle inlet wall is fitted to the first plate surface of the second needle inlet plate, and when the vertical arm moves to the first position, the clip opening is clamped onto the lock-block; wherein the first clamping part can move between a first clamping part position and a second clamping part position, thereby enabling two snap-on connections between the first clamping part and the second clamping part, the two snap-on connections each comprises: in the first position, the positioning block on the first side end of the rocking arm is clamped into the positioning hole of the buckle plate; with the clip opening of the vertical arm is clamped onto the lock-block; in the second position, the positioning block is disengaged from the positioning hole, and the clip opening of the vertical arm is disengaged from the lock-block , so that the first needle inlet plate and the second needle inlet plate are separated by translating in a direction perpendicular to an insertion direction of a puncture needle as taught by Shikata, because this can reduce the time for sterilization, thereby improving the throughput of an examination [0084].
Regarding Claim 11, Sasady discloses that the first needle inlet plate and the second needle inlet plate are sector-shaped plates, comprising an arc-shaped end and a circle center end (See Fig. 1 for arc shaped and circle center end);
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wherein first ends of the plurality of semi-open needle inlet channels are needle introduction ports, which are arranged at the arc-shaped end of the second needle inlet plate, and second ends of the plurality of semi-open needle inlet channels are communicated to form a needle release port, which is arranged at the circle center end of the second needle inlet plate (See Fig. 3 for needle release port at circle center of the second needle inlet plate).
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Claims 3-9, & 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Sasady in view of Shikata as applied to Claim 2 above, and further in view of Nygaard et al (US20170035385A1; hereinafter referred to as Nygaard).
Regarding Claim 3, Sasady discloses that the arc-shaped end of the second needle inlet plate is provided with a hand position arm (projecting grip 4 c), which is perpendicular to a second plate surface of the second needle inlet plate (“The rotatable handle 4 is provided with a projecting grip 4 c facilitating operation thereof.” [Sasady 0018], see Fig. 3 for hand position arm 4c)
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Sasady in view of Shikata do not specifically disclose that the arc- shaped end of the first needle inlet plate is provided with a plurality of labels, which are located on an end face of the arc-shaped end of the first needle inlet plate and on the side of the needle introduction port.
However, in the similar field of ultrasonic probe needle guides, Nygaard teaches an instrument guide for a probe head of an ultrasound imaging probe including a guide bracket [Abstract].
Nygaard also teaches that the arc- shaped end of the first needle inlet plate is provided with a plurality of labels, which are located on an end face of the arc-shaped end of the first needle inlet plate and on the side of the needle introduction port (“The tap 237 includes indicia 316, which identifies an angle of each of the slots 314.” [0048], see Figure 3 for labels (indica 316) on arc shaped end).
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It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Sasady in view of Shikata as outlined above with the arc-shaped end of the first needle inlet plate is provided with a plurality of labels, which are located on an end face of the arc-shaped end of the first needle inlet plate and on the side of the needle introduction port as taught by Nygaard, because this allows for selecting a guide based on instrument insertion angle [0030].
Regarding Claim 4, Sasady discloses that a first end of the rocking arm is provided with a fixing hole (centre of rotation 4b), and a second plate surface of the first needle inlet plate is provided with a rotating boss (centre of rotation 4b) which is sleeved with the fixing hole; the protruding positioning block (projecting spring pre-stressed ball in the handle 4) is driven by the rocking arm to move between the first position and a second position with the rotating boss as a center of circle (inserted in corresponding recesses 9 in the device) (“The rotatable handle 4, being rotatable about the centre of rotation 4 b, is fixated in each of the aforementioned positions by means of a projecting spring pre-stressed ball in the handle 4, which can be inserted in corresponding recesses 9 in the device. The rotatable handle 4 is provided with a projecting grip 4c facilitating operation thereof.” [0018], see Fig. 3 for the features listed above although the projecting spring pre-stressed ball in the handle cannot be seen the function is the same as the protruding positioning block);
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Regarding Claim 5, Sasady discloses the arc shaped end of the first needle inlet plate is provided with a first chute along the arc-shaped surface thereof, and a first positioning protrusion and a second positioning protrusion are arranged at two ends of the first chute respectively; a second end of the rocking arm is provided with a rocking block, wherein the side of the rocking block that is fitted to the second plate surface of the first needle inlet plate is provided with a clamping opening, in which a positioning snap is provided on the inner wall at the top thereof; the positioning snap is clamped into the first chute, and a first positioning groove and a second positioning groove are arranged at two sides of the positioning snap respectively; when the rocking arm is in the first position, the first positioning protrusion is clamped into the first positioning groove, and when the rocking arm is in the second position, the second positioning protrusion is clamped into the second positioning groove (“The inner side of the needle guide 5 is provided with a plurality of grooves 5 b, each groove having an individual angle position, so that the physician is free to choose the angle position best suitable for the conditions when taking samples from internal organs of a patient. It appears from FIG. 4 that three grooves 5 a are provided, each with their own angle position. Several different needle guides can be arranged for needles of different thickness.” [0019], see Fig 4. for the chute along the arc shaped end with protrusion on either side, see Fig. 3 for rocking block holding the position of the rotatable handle and defining the grooves 5b seen in Fig. 4).
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Regarding Claim 6, Sasady discloses the side of the rocking block that is away from the second plate surface of the first needle inlet plate is provided with a boss and first anti-slip ridges (See Fig. 3 for the boss on the side away from the second plate surface using anti slip ridges would not be novel in the art).
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Regarding Claim 7, Sasady discloses a first side end of the first needle inlet plate is provided with a first retaining wall and a second retaining wall extending in the direction away from the first needle inlet plate along the plane in which the first needle inlet plate is located, and a space is arranged between the first retaining wall and the second retaining wall to form a first notch; wherein when the needle inlet wall of the first needle inlet plate is fitted to the first plate surface of the second needle inlet plate, the buckle plate is inserted into the first notch, and abuts against the first retaining wall and the second retaining wall (See Fig. 4 for retaining walls provided on the first side of the first needle inlet plate and the buckle plate (needle guide 5 inserted into the notch).
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Regarding Claim 8, Sasady disclose all limitations noted above except that the first needle inlet plate further comprises a connecting arm, which is located on a second side end of the first needle inlet plate; wherein the plane in which the first needle inlet plate is located is perpendicular to the surface of the connecting arm, and a space is arranged between the surface of the connecting arm and the first needle inlet plate, thereby forming a second chute, a top end and a bottom end of the connecting arm being fixedly connected with an extending portion of the second side end of the first needle inlet plate respectively; the vertical arm is located in the second chute; a protruding shaft is vertically arranged on a second plate surface of the slider arm; the side of the rocking arm that is fitted to the second plate surface of the first needle inlet plate is provided with a strip-shaped third chute, in which the protruding shaft is arranged; the rocking of the rocking arm makes the strip-shaped third chute drive the protruding shaft to move, so that the vertical arm moves between a first position and a second position of the second chute.
However, in a similar field of endeavor, Shikata teaches that the first needle inlet plate further comprises a connecting arm, which is located on a second side end of the first needle inlet plate; wherein the plane in which the first needle inlet plate is located is perpendicular to the surface of the connecting arm, and a space is arranged between the surface of the connecting arm and the first needle inlet plate, thereby forming a second chute, a top end and a bottom end of the connecting arm being fixedly connected with an extending portion of the second side end of the first needle inlet plate respectively (“The following describes the engagement state in the through hole 475 with reference to FIG. 16. FIG. 16 is a view for explaining the engagement state in the through hole 475 according to the modification of the second embodiment. FIG. 16 is a top view of the adapter 460 viewed from the gripper 12 side. As illustrated in FIG. 16, the connection 461 of the pressing part 480 is inserted into the through hole 475 formed in the guide part 470, thereby engaging with the through hole 475. More specifically, the second area 461 b inserted into the through hole 475 engages with the guide part 470 at A illustrated in FIG. 16. When the second area 461 b engages with (is hooked and caught by) the guide part 470, the guide part 470 and the pressing part 480 are temporarily fixed and can be separated.” [0125].
a vertical arm is vertically arranged on a first plate surface of the slider arm, and the vertical arm is located in the second chute; a protruding shaft is vertically arranged on a second plate surface of the slider arm; a side of the rocking arm that is fitted to the second plate surface of the first needle inlet plate is provided with a strip-shaped third chute, in which the protruding shaft is arranged (“Subsequently, the first hinge 491 of the fixing part 490 is inserted into the through hole 475 with the second area 461 b engaging with the guide part 470. Thus, the first hinge 491 engages with the connection 461. More specifically, the first hinge 491 inserted into the through hole 475 engages with the second area 461 b at B illustrated in FIG. 16. The first hinge 491 engages with the second area 461 b with the second area 461 b engaging with the guide part 470, whereby the guide part 470, the pressing part 480, and the fixing part 490 are fixed and integrated.” [0126]);
the rocking of the rocking arm makes the strip-shaped third chute drive the protruding shaft to move, so that the vertical arm moves between the first position and a second position of the second chute (“The first area 461 a of the connection 461 is bent, thereby bringing the second surface 480 b of the pressing part 480 into contact with the surface 470 a of the guide part 470. In this state, the coupling area 493 is bent, whereby the second hinge 492 sandwiches the guide part 470 and the pressing part 480. The pressing part 480 fits into the recess 18 on the first surface 16 of the cutout portion 15, and the guide part 470 fits into the recess 19 of the cutout portion 15. Subsequently, the second hinge 492 is fastened to the first surface 16 of the cutout portion 15 with the guide part 470 and the pressing part 480 sandwiched therebetween. Thus, the adapter 460 is fixed to the probe body 10. In other words, by bending the connection 461 in the state of being inserted into the through hole 475, the guide part 470 and the pressing part 480 are fixed to the probe body 10 with the surface 470 a of the guide part 470 brought into contact with the second surface 480 b of the pressing part 480.” [0127]).
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It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Sasady as outlined above with the first needle inlet plate further comprises a connecting arm, which is located on a second side end of the first needle inlet plate; wherein the plane in which the first needle inlet plate is located is perpendicular to the surface of the connecting arm, and a space is arranged between the surface of the connecting arm and the first needle inlet plate, thereby forming a second chute, a top end and a bottom end of the connecting arm being fixedly connected with an extending portion of the second side end of the first needle inlet plate respectively; the vertical arm is located in the second chute; a protruding shaft is vertically arranged on a second plate surface of the slider arm; the side of the rocking arm that is fitted to the second plate surface of the first needle inlet plate is provided with a strip-shaped third chute, in which the protruding shaft is arranged; the rocking of the rocking arm makes the strip-shaped third chute drive the protruding shaft to move, so that the vertical arm moves between a first position and a second position of the second chute as taught by Shikata, because this can reduce the time for sterilization, thereby improving the throughput of an examination [0084].
Regarding Claim 9, Sasady disclose all limitations noted above except that a first side end of the connecting arm is provided with a stop block, which is arranged vertically on the surface of the connecting arm, and which is provided with a second notch.
However, in the similar field of needle guides, Shikata teaches a first side end of the connecting arm is provided with a stop block, which is arranged vertically on the surface of the connecting arm, and which is provided with a second notch (“The first area 461 a of the connection 461 is bent, thereby bringing the second surface 480 b of the pressing part 480 into contact with the surface 470 a of the guide part 470. In this state, the coupling area 493 is bent, whereby the second hinge 492 sandwiches the guide part 470 and the pressing part 480. The pressing part 480 fits into the recess 18 on the first surface 16 of the cutout portion 15, and the guide part 470 fits into the recess 19 of the cutout portion 15. Subsequently, the second hinge 492 is fastened to the first surface 16 of the cutout portion 15 with the guide part 470 and the pressing part 480 sandwiched therebetween. Thus, the adapter 460 is fixed to the probe body 10. In other words, by bending the connection 461 in the state of being inserted into the through hole 475, the guide part 470 and the pressing part 480 are fixed to the probe body 10 with the surface 470 a of the guide part 470 brought into contact with the second surface 480 b of the pressing part 480.” [0127], “In the modification of the second embodiment, the third surface 470 a of the guide part 470 has the guide grooves 471, and the second surface 480 b of the pressing part 480 has the guide grooves 481, for example. The guide grooves that guide the puncture needle may be formed on at least one of the third surface 470 a of the guide part 470 and the second surface 480 b of the pressing part 480. The third surface 470 a of the guide part 470 may have the guide grooves 471, and the second surface 480 b of the pressing part 480 may have no guide groove, for example. Alternatively, the third surface 470 a of the guide part 470 may not have the guide grooves 471, and the second surface 480 b of the pressing part 480 may have the guide grooves 481.” [0128])
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It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Sasady as outlined above with a first side end of the connecting arm is provided with a stop block, which is arranged vertically on the surface of the connecting arm, and which is provided with a second notch as taught by Shikata, because this can reduce the time for sterilization, thereby improving the throughput of an examination [0084].
Regarding Claim 12, Sasady and Zeng discloses that the arc-shaped end of the second needle inlet plate is provided with a hand position arm (projecting grip 4 c), which is perpendicular to a second plate surface of the second needle inlet plate (“The rotatable handle 4 is provided with a projecting grip 4 c facilitating operation thereof.” [Sasady 0018], see Fig. 3 for hand position arm 4c)
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Sasady and Zeng do not specifically disclose that the arc- shaped end of the first needle inlet plate is provided with a plurality of labels, which are located on an end face of the arc-shaped end of the first needle inlet plate and on the side of the needle introduction port.
However, in the similar field of ultrasonic probe needle guides, Nygaard teaches an instrument guide for a probe head of an ultrasound imaging probe including a guide bracket [Abstract].
Nygaard also teaches that the arc- shaped end of the first needle inlet plate is provided with a plurality of labels, which are located on an end face of the arc-shaped end of the first needle inlet plate and on the si