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 .
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 1-10 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 “limitation part is controlled such that the movable distance of the second adapter is changed”. It is not clear from the claim language how the limitation part is controlled to result in the changing distance of the second adapter. As per the specification, “the stopper 430 is positioned close to the front end of the limitation part body 410, the movable distance of the second adapter part 200 become relatively long. When the stopper 430 is positioned close to the rear end of the limitation part body 410, the movable distance of the second adapter part 200 becomes relatively short” [0118]. It is suggested claim 1 language be clarified with respect to changing distance of the second adapter part with respect to the positioning of the stopper relative to the front/rear end of the limitation body part.
The dependent claims do not provide additional clarity and therefore stand rejected under 112(b).
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) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asai (JP 2021101930 A (as set forth in the IDS 8/5/2025) in view of Gasperment et al. (2020/0237437).
With respect to claim 1, Asai teaches of an invasive instrument guide device (fig. 1) comprising a first adapter part 2 or base (fig. 1) configured to be coupled with a probe 101 (fig. 1) of ultrasound device 100 that radiates an ultrasound beam toward a target location or blood vessel T [0023-0025] and to fix a location of the probe [0027, as shown in fig. 1A/B]. Asai teaches of a second adapter 4 or holder (fig. 1) configured to be coupled with an invasive instrument 50 or puncture tool (fig. 1) and to be moved together with the invasive instrument 50 or where the puncture guide guides the puncture tool by moving it in a straight line so that the needle tip of the puncture tool can puncture a puncture target and the ultrasound device is used in combination. [0023, 0027, 0032, 0034, 0035]. Asai teaches of a guide part which is the combination of the rail 3, slider 21, groove part 22, and holding body part 20 (fig. 1) configured to be connected to the second adapter 4 and guide the second adapter through its movement along a longitudinal direction of the invasive instrument 50 [0023, 0027, 0032, 0034, 0035].
Asai further teaches of a limitation part 13 guide groove (fig. 2) in combination with angle adjustment 5 and end of 13 or guide groove and near connecting end 12 (fig. 2) and configured to be arranged on a movement path of the second adapter 4 or holder and would under broadest reasonable interpretation, limit a movable distance of the holder 4, wherein the limitation part 13 is controlled such that the movable distance of the second adapter part or holder 4 is changed (fig. 2) due to combination of the limitation part and angle adjustment mechanism. Asai teaches of the holder 4 or second adapter part sliding linearly along the guide edge portion 3T of the rail 3 in the tip end side X1 direction and base end side X2 direction (fig. 2A-D [0035]) and therefore the guide groove is controlled such that the movable distance of the second adapter or holder 4 is changed.
While the Asai reference’s teaching of the end of 13 (guide groove) near 12 (connecting end) could be interpreted as the stopper configured to limit a movable distance of the holder 4 or second adapter, the reference does not explicitly teach of a stopper. In a similar field of endeavor Gasperment et al. teach of an invasive instrument guide device comprising needle assembly 200 with stopper 236 disposed on the handle to prevent actuator 216 from moving pas a desired distal point and aids in limiting the distance the therapeutic portion 212 may extend from port 210 [0052]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Gasperment et al. to modify Asai to aid in limiting the movable distance of the second adapter part [Gasperment, 0050].
With respect to claim 2, Asai in view of Gasperment et al. teach of the first adapter 2 or base configured such that the probe 101 is coupled and fixed thereto (fig. 1) and an adapter body (3, 20, 21, 22, 13, and 5) configured to be connected to the probe fixation portion (fig. 2A) to accommodate the guide part (rail/slider/groove part and holding body part) and the limitation part (guide groove in combination with angle adjustment and stopper guide groove and connecting end) in an internal space thereof (fig. 2).
With respect to claim 3, Asai in view of Gasperment et al. teach of the second adapter part or holder 4 to comprise an invasive instrument fixation portion 55 or connecting end configured such that the invasive instrument is coupled and fixed thereto where 50 or puncture tool is coupled to 55 along with the combination of the rail 3, holding main body part 20, slider 21, groove part 22, guide groove 13 and angle adjustment mechanism 5 (fig. 1, 2).
With respect to claim 4, Asai in view of Gasperment et al. teach of the invasive instrument to comprise a needle part 51 configured to invade the body and a coupling part configured to be connected to the needle 51 and coupled to the invasive instrument fixation portion 55 (fig. 1).
Claim(s) 5-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asai in view of Gasperment et al. and further in view of Martin et al. (9883858) with evidentiary support from Krulevitch et al. (2012/0004637).
With respect to claims 5 and 8, Asai teaches of a limitation part body part 13 guide groove (fig. 2) in combination with angle adjustment 5 and stopper (end of 13) guide groove and near connecting end 12 (fig. 2) and configured to be arranged on a movement path of the second adapter 4 or holder and an angle adjustment mechanism configured to be connected to one side of the limitation part body (as shown in figure 2, [0033, 0034]) in a longitudinal direction and to be rotated by an external force [0033-0035], wherein the stopper (end of 13) guide groove (fig 2) is connected to one side of the limitation body part (near connecting end 12) in a radial direction and is arranged on a movement path of the second adapter part 4 [0033-0035].
With respect to claims 5 and 8-10, Asai teaches of adjusting the angle but does not teach of a rotary knob with gauge specification of a needle. Gasperment et al. teach of the use of deploying features such as knobs [0052]. In a related field of endeavor Martin et al. teach of a suturing instrument coupled to a robotic control system that includes a needle applier cartridge 30 with a spring biased trigger to return the trigger to its open position with a second input such as a rotary knob to selectively articulate shaft 20 and a third input 16 or rotary knob which may be used to selectively rotate needle applier cartridge 30 about shaft 20 and the number type, configuration and operation of inputs 12, 14, 16 may vary (fig. 1, col. 4 lines 61-col. 5 line 3). It is well known in art for the rotary knob to include numbers on the knob to indicate the gauge/needle/dosage specifications to make adjustments as per requirements of the procedure (as evidence by the rotary knob 278 with dosage selector 220 in Krulevitch), [0048, fig. 4, 10]. With respect to claims 9 and 10, the combination of the references would allow for the rotation of the rotary knob with the limitation part 13 in combination with the angle adjustment and stopper to allow for adjustments to be made with respect to the needle and movement of the stopper in forward or rearward along the longitudinal direction along the or sliding of the holder 4 attached to the rail 3 in the direction of the tip end side X1 and the proximal end side X2 on the outside of the rail 3 (fig. 12).
With respect to claims 6 and 7, Asai in view of Gasperment et al. in view of Martin et al. teach of the limitation part body having a cylindrical shape (fig. 2) and is provided with a spiral stopper movement groove or guide groove 13 formed along an outer circumferential surface (fig. 2) and where the stopper is configured such that one side is connected to the stopper movement groove or recess 2G and a remaining side thereof is connected to the guide part which is the combination of the rail 3, slider 21, groove part 22, and holding body part 20 (fig. 1, 2). Gasperment et al. teach of the stopper 236 with spiral grooves 230 formed along an outer circumferential surface (fig. 2I, 0052) and as shown in the figure, one side of the stopper 236 is connected to the groove part 230 and the remaining side is connected to the guide part.
It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Martin et al. to modify Asai to allow for various selections and adjustments to be made to allow for insertions to be more accurate and more consistent across different needle lengths.
Conclusion
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BR
/BAISAKHI ROY/ Primary Examiner, Art Unit 3797
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