DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 3 and 7-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 19, 2026.
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, 2, 4-6, and 14-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shu (JP 2018-171231; submitted in the IDS filed September 19, 2022).
Regarding claim 1, Shu discloses (Figures 1-3; it is noted that the citations herein are taken from the English translation retrieved from Espacenet patent search online) a medical puncture needle comprising: a metal needle body (110) formed in a tubular shape, the needle body comprising: a blade surface (120S) located at a distal end portion of the needle body (Figure 1), a planar reflection portion (prism inclined surface 171) and configured to reflect light (¶ [0041]), and a transmission window (hole 125) located proximal of the blade surface (see Figure 3, the inclined reflection surface is proximal of the tip of the needle) and configured to transmit reflected light reflected b the planar reflection portion (¶ [0042] describes the light reflecting through the hole to be collected by lens 160).
Regarding claim 2, Shu further discloses wherein the blade surface is inclined with respect to an axis of the needle body (Figures 1-2, the needle tip is angled with respect to the needle body); the needle body comprises a first wall portion located below the axis of the needle body in a horizontal state of the needle body in which the axis of the needle body is located in a horizontal direction such that the blade surface faces upward, and a second wall portion located above the axis of the needle body in the horizontal state; and the transmission window is located in the second wall portion (see Figure 5, the hole begins in portion 126 which is proximal of the planar reflection portion 171 and on an open side of the needle; the first wall portion comprises at least a portion of the reflection portion and the tip of the needle extending distal from the opening defining the hole for transmitting light).
Regarding claim 4, Shu further discloses wherein the planar reflection portion is located at an inner surface of the first wall portion over part of a length of the needle body in a longitudinal direction (Figure 5, the reflection portion 171 extends from adjacent the tip of the needle in a proximal direction on the inner surface of the needle as claimed).
Regarding claim 5, Shu further discloses wherein the planar reflection portion is located at an inner surface of the first wall portion (it extends along the inner surface adjacent the distal end of the needle), and the planar reflection portion and the transmission window face each other (Figure 5, opening 125 forming the window is located opposite the planar reflection portion as claimed).
Regarding claim 6, Shu further discloses wherein the transmission window (125) is configured to transmit the light so that the light is introduced into a lumen of the needle body from an outside of the needle body (the planar reflection portion is considered fully capable of reflecting light from any source including outside of the needle body).
Regarding claim 14, Shu further discloses wherein, in the axial direction of the needle body, the transmission window (125) is located at a distance in a range within 2 mm in a proximal end direction from a proximal end of the blade surface (the transmission window 171 is formed in the needle body and extends to the edge of the needle tip thereby placing it 0 mm from the proximal end of the needle tip which is less than 2 mm as claimed).
Regarding claim 15, Shu further discloses wherein the transmission window (125) is configured to transmit near-infrared light (the exposure hole is considered fully capable of transmitting any wavelength of light therethrough even if outside of the desired range of the light receiving apparatus).
Regarding claim 16, Shu further discloses wherein the transmission window comprises: a through hole formed in the needle body (Figure 5), and a transmission member disposed to close the through hole (prism outer surface 170 covers the hole as depicted in Figure 3; see also ¶ [0070]).
Regarding claim 17, Shu discloses the puncture needle of claim 1 as above, and a catheter shaft (catheter 20 with body 21, Figure 1) having a lumen through which the needle body is inserted.
Regarding claim 18, Shu discloses a vascular puncture system comprising: a medical puncture needle (10) comprising: a metal needle body (e.g., ¶ [0079] discloses that the needle body may be metal) forming in a tubular shape, the need body comprising: a blade surface (120S, Figure 2) located at a distal end of the needle body (Figures 1-2), a planar reflection portion (inclined surface 171 of prism 170) located at an inner surface of the needle body and configured to reflect light (Figures 2, 3, and 5; ¶ [0041]), and a transmission window (opening formed by hole 125) located proximal of the blade surface (Figure 5) and configured to transmit reflected light reflected by the planar reflection portion (¶ [0027], the light is irradiated from the distal end through the exposure hole 125); an irradiation unit (light source 191 and fiber optic cable 150; Figure 4) configured to irradiate a puncture target site with the needle body with the light; and a light receiving unit (194; ¶¶ [0049]-[0054]) configured to receive the reflected light by the puncture target site and the needle body (Figure 4, the light is generated by 191, passes through the needle and is reflected to receiving unit 194).
Regarding claim 19, Shu further discloses wherein each of the irradiation unit (191) and the light receiving unit (194) is configured to be disposed above the puncture target site and the needle body (see Figure 1, the light generating/receiving unit 190 is outside of the proximal end of the device as claimed).
Regarding claim 20, Shu further discloses wherein the irradiation unit (191) is configured to radiate the light from a distal end opening (via fiber optic cable 150 and end 150b, Figures 4-5) or a proximal end opening of the needle body (the fiber optic cable enters from the proximal end as depicted in Figure 1 so it can be considered to irradiate from either the proximal or distal end) toward the planar reflection portion (171); and the light receiving unit (194) is configured to be disposed above the transmission window (it’s out the proximal end of the device which is above the transmission window 125 as claimed).
Regarding claim 21, Shu discloses a method of determining whether a distal end opening of a needle body is located in a blood vessel, the method comprising: providing a medical puncture needle (10) comprising: a metal needle body (110; ¶ [0079])formed in a tubular shape (Figures 1-2), the needle body comprising: a blade surface (120S, Figure 2) located at a distal end portion of the needle body and comprising a distal end opening (e.g., 210L1, Figure 7; ¶ [0080]), a planar reflection portion (171) located at an inner surface of the needle body and configured to reflect light (Figure 5, ¶ [0041]), and a transmission window (opening 125) located proximal of the blade surface (Figure 5) and configured to transmit a reflected light reflected by the planar reflection portion (¶¶ [0041]-[0042]); providing an irradiation unit (191, Figure 4) at a position above a puncture target (the unit is housed external to the catheter and needle) site of a living body; providing a light receiving unit (194, Figure 4) at a portion above a puncture target site of a living body (the light receiving portion is also external to the catheter and needle as seen in Figure 1); irradiating the puncture target site with light from the irradiation unit (¶ [0073] discloses the irradiation of the site using the light source, its reflection on the surface 171 and reading via receiver 194); puncturing the puncture target site with the needle body (¶ [0078] discloses puncturing the site at a desired angle results in the light output reading to determine if the needle is properly positioned); receiving the reflected light reflected by the planar reflection portion at the light receiving unit (¶ [0054]); adjusting a position of the blade surface (¶ [0064] discloses inserting the needle until the unit 196 alerts the user, based on the reflection data received from the receiver 194, that the needle has entered the blood vessel as desired); and determining whether the distal end opening of the needle body is located in the blood vessel by viewing an image of the reflected light (see e.g., ¶¶ [0054] and [0057] disclose using the reflected light intensity value along with the intensity of the light source to determine whether or not the needle has entered the blood vessel which is considered an image of the irradiation of the site as no software output or image viewing clarification is in the claims).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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