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 .
Response to Amendments
The Amendment filed 01/28/2026 has been entered.
Claims 1-27, 29, 30, and 34 are cancelled.
Claims 28, 31-33, and 35-50 remain pending in the application.
Applicant’s amendments to the claims have overcome each and every objection previously set forth in the Final Office Action mailed 11/03/2025.
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 28, 31, 32, 35, 36, 38-43, 47, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn et al. (U.S. Patent No. 9888881), hereinafter Hulvershorn, and further in view of Hendriks et al. ( U.S. Publication No. 20140121538), hereinafter Hendriks, and further in view of Gorhan et al. (U.S. Patent No. 9717434), hereinafter Gorhan.
Regarding Claim 28, Hulvershom discloses a needle (20; Figs. 2A,2G, and 4A-B) for a syringe, comprising: a tip (tip/distal segment (204)) at one end (distal end of probe (200) as seen in Fig.4A) of the needle, adapted to penetrate a body tissue during usage of the syringe
(50) (columns 20 (lines 64-67)- 21 (lines 1-4)); a hub (probe sensing fitting (208)) at another end (proximal end (206)) of the needle, to attach the needle to a tube or to the syringe (columns 20 (lines 64-67)- 21 (lines 1-4)); a shaft (probe's shaft (202)), wherein a lumen (conduit) of the needle is a space delimited by a continuous surface inside (inner surface of probe's shaft (202)) the shaft (the probe's shaft 202 can include a conduit therethrough to facilitate such fluid communication; column 20 (lines 65-66)); wherein the shaft (202) comprises an inner wall (see below);a pressure sensor (sensing elements (210)) (the sensing elements (210) can be a set of pressure sensors) (column 20, lines 30-35) in the needle (the sensing elements (210) are located within the probe (200) as seen in Fig.4A); wherein the pressure sensor (210) comprises an external surface (outer surface of the sensing elements (210)); and a system (signal interface elements (228); Fig.4A) to transmit outside the needle a pressure value sensed by the pressure sensor in the needle (the signal interface elements
(228) transfer the signal between the set of sensing elements/pressure sensors (210) and the
AECD (102; Fig. IC) (column 20, lines 52-55) wherein a processing unit (160; Fig. IC) in the
AECD (102) determines a vascular pressure value (column 21, lines 41-44) and that the fluid drawn into or flow within the conduit in the probe's shaft (202) is subjected to sensing or analysis (columns 20 (lines 64-67)- 21 (lines 1-4)), wherein the system to transmit is fixed inside the hub (the sensing interface elements (228) are fixed to/carried by the probe sensing fitting (208) (The signal interface elements 322 carried by the AECD sensing fitting 320 are configured to structurally mate with and functionally correspond to the signal interface elements 228 carried by the probe sensing fitting 208; column 21, lines 15-18), the pressure
sensor (210) is not fixed to the surface inside the shaft of the needle (the sensing fitting (208) surrounds/encapsulates a portion of the set of sensing elements (210). The sensing elements
(210) are not fixed to the probe' s shaft (202), since the probe sensing fitting (208) is a female luer lock fitting inserted within the shaft and the sensing elements is surrounded with the female luer lock fitting) (column 20, lines 40-45), wherein the pressure sensor is maintained in a floating position inside the shaft (the sensing fitting (208) surrounds/encapsulates a portion of the set of sensing elements (210). The sensing elements (210) are floating within the probe' s shaft (202), since the probe sensing fitting (208) is a female luer lock fitting inserted within the shaft and the sensing elements is surrounded with the female luer lock fitting) (column 20, lines 40-45), and the pressure sensor measures pressure of fluid in the shaft (the fluid drawn into or flow within the conduit in the probe's shaft (202) is subjected to sensing or analysis (columns 20 (lines 64-67)- 21 (lines 1-4)), wherein the hub (208) is attached to said another end (206) of the needle (Figs.2A, 2G, and 4A), the hub comprising a port (see below) to connect the needle to the tube or to the syringe (columns 20 (lines 64-67)- 21 (lines 1-4)), and the hub comprising a structure (see below) extending from said another end (206) of the needle to the port (the structure extends from the proximal end (206) to the port as seen in Fig.4A and
below), wherein the structure (see below) of the hub includes a wall having an inner surface (see below) delimiting an inner volume (space within the probe sensing fitting (208)) of the hub and an outer surface (see below) opposite to the inner surface of the wall (the outer surface is opposite to the inner surface as seen below).
Hulvershorn, in the embodiment of Figs. 2A,2G, and 4A-B, does not appear to disclose a cable comprising a face, a first end optically or electrically connected to the pressure sensor in the needle wherein the first end is attached to the pressure sensor, a second end which exit from the needle through said another end of the needle, and a portion between the first end and the second end inside the needle. Hulvershorn, embodiment of Figs. 2A,2G, and 4A-B, does not disclose the face of the cable and the external surface of the sensor directly oppose the inner wall of the shaft and that the cable is fixed to the hub and adapted to maintain the pressure sensor within the needle and that the pressure sensor is maintained within the needle at a predetermined distance from the tip or from a bevel of the needle, said predetermined distance from the tip or bevel from 1% to 20% of a length of the needle. Hulvershorn does not disclose the cable avoids fluctuation of the pressure sensor in the needle, the second end of the cable exits from the hub through the wall of the hub and not through the port, and the cable is fixed in the wall of the hub and not to the port. Hulvershorn, embodiment of Figs. 2A,2G, and 4A-B, does not disclose the portion of the cable is also in the inner volume of the hub and the second end of the cable crosses the inner surface and the outer surface to exit from the hub.
However, Hulvershorn, in the embodiment of Fig5SB, teaches it was known in the art to
have an optical fibers/electrical leads (410) comprising a face (face/external surface of the optical fiber/electrical leads (410)), first end (end of the optical fibers (410) where the sensing devices (412) is located) connected to the optical elements/sensing devices (412) in the
needle/probe (20), a second end (the end that exits the probe's coupling structure (28) as seen in Fiug.5B) wherein the second end of the electrical leads (410) exits from the probe's coupling structure (28), and a portion between the first end and the second end inside the needle (the portion of the optical fibers (410) located within the needle's shaft (22) between the first and the second ends) (columns 21 lines 63-67)- 22 (lines 1-2)). Hulvershorn, in the embodiment of Fig.SB, teaches the face of the optical fibers (410) and the external surface (outer surface) of the sensing devices (412) (similar to sensing elements (210) in Fig.4A) oppose the inner wall of the shaft as seen in Fig.5A and that the optical fibers (410) are fixed to/carried by the probe needle's coupling structure (28) as seen in Fig.5B. The optical fibers are fully capable of maintaining the sensing elements (210) (in the embodiment of Figs. 2A,2G, and 4A-B) within the needle (20), since the optical fibers (410) maintains the optical elements/sensing devices (412) within the needle as seen in Fig.5B.
It would have been obvious to one having ordinary skill in the art before the effective
filing date of the claimed invention to have modified Hulvershom to incorporate the teachings of the embodiment in Fig.SB to have a cable comprising a face, a first end (end optically or electrically connected to the pressure sensor), a second end (end that exit from the needle through said another end of the needle and exits the hub through the structure of the hub), a portion between ends wherein the face of the cable and the external surface directly oppose the inner wall of the shaft and adapted to maintain the pressure sensor within the needle in order to facilitate the sensing operation (column 21, lines 25-34).
Hendriks teaches it was known in the art to have optical fibers (300; Fig.I) comprising a second end (end that exits a holder part (120); Fig.5) that exits from the holder part (120) through a wall of the holder part (120) and not through connector (130). The optical fibers (300) are fixed to the wall and not through the connector (130) as seen in Figs. 1 and 5. Modifying the exit of the modified cable (the optical fiber/electrical leads (410) of embodiment of Fig.SB of Hulvershom) through the hub is fully capable of avoiding fluctuation of the sensing elements within the shaft of Hulvershorn. Hendricks teaches a portion of the cable (portion between the front surfaces
(310) and the end that exits the holder part (120)) is within the inner volume of the holder part
(120) and the second end (end that exits a holder part (120)) of the optical fibers (300) crosses the surfaces of the holder part (120) (parag. [0066]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hulvershom to incorporate the teachings of Hendriks to have a cable that avoids fluctuation of a pressure sensor in the needle wherein the cable is fixed in a wall of a hub and not a port, a second end of the cable exits from the hub through the wall of the hub and not through the port, and a portion of the cable is also in an inner volume of the hub and the second end of the cable crosses an inner surface and an outer surface to exit from the hub in order to easily pull back the insert to deliver fluid (parag. 0026]) and applicant appears to have placed no criticality on the claimed location/connection of the cable (cable ''may'' be fixed to the hub; page 19, lines 27-28 in the specification).
Gorhan teaches it was known in the art to have a distal end of a fibre optic pressure sensor is arranged at a distance of a maximum of 5 cm (column 8, lines 23-25) that is within 1%-20% (1 cm-20 cm) if that total length of the perfusion cannula is 100 cm (column 4, lines 42-43).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hulvershom to incorporate the teachings of Gorhan to have a pressure sensor maintained within a needle at a predetermined distance from a tip or from a bevel of the needle, said predetermined distance from the tip or bevel from 1% to 20% of a length of the needle in order to measure the precisely measure the pressure at the position of the distal end of the sensor (column 8, lines 23-29).
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Regarding Claim 31, Hulvershorn as modified, in the embodiment of Figs. 2A,2G, and 4A-B, discloses the needle according to claim 28 and further discloses wherein the sensor includes a sensing surface arranged to be contacted by the fluid to be injected with the syringe (In another embodiment, the probe's shaft 202 can include a conduit therethrough to facilitate such fluid communication. In an embodiment in which the probe's shaft is substantially hollow or includes a conduit, a bodily fluid can flow or be drawn into the AECD 100, 102, 104 for sensing or analysis, and/or into a syringe 50 that is coupled to the AECD 100, 102, 104; columns 20 (lines 65-67)- 21 (lines 1-4)), and being adapted to measure a pressure of the fluid around the bevel, and/or a variation of the fluid pressure around the bevel (column 12, lines 18-44).
Regarding Claim 32, Hulvershom as modified, in the embodiment of Figs. 2A,2G, and 4A-B, discloses the needle according to claim 31 and further discloses wherein the sensing surface includes at least a portion perpendicular to an axis of the needle (see figure below),
said portion being towards the tip of the needle (the sensing elements (210) are located adjacent to the distal segment/tip (204) as seen in Fig.4A).
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Regarding Claim 35, Hulvershom as modified, in the embodiment of Figs. 2A,2G, and 4A-B, discloses the needle according to claim 28, and Hulvershom, in the embodiment of Fig.SB, further teaches wherein the second end of the cable includes a wireless interface to transmit wirelessly the pressure value to a device (remote or external computer system (90)) outside the needle (column 21, lines 25-34) (A remote or external end of the sensing
guidewire 400 can be coupled to a remote or external computer system or medical device 90, 92; column 22, lines 5-7).
Regarding Claim 36, Hulvershom as modified, in the embodiment of Figs. 2A,2G, and 4A-B, discloses the needle according to claim 28, and Hulvershom, in the embodiment of Fig.SB, further teaches wherein the cable is an optical fibre (column 21, lines 65-67).
Regarding Claim 38, Hulvershom as modified, in the embodiment of Figs. 2A,2G, and 4A-B, discloses a system including a device (AECD (104); Fig.2A) connected or connectable to the system (228) to transmit of the needle (the set of signal interface elements 228 can include one or more of an optical fiber interfaces or lens, or an electrical contact or pin. Such signal interface elements 228 can reside at predetermined positions relative to the probe sensing fitting 208, and mate with a particular portion of the AECD I 00, I 02, I 04 in a specified manner to facilitate reliable signal communication; column 20, lines 55-61) according to claim 28, to control the pressure in the needle (column 27, lines 10-18).
Regarding Claim 39, Hulvershom as modified, in the embodiment of Figs. 2A,2G, and
4A-B, discloses the system of claim 38, and Hulvershorn, in the embodiment of Fig.SB, further teaches wherein said second end (the end that exits the probe's coupling structure (28) as seen in Fiug.5B) of the cable is connected to the device (104) (the second end of the optical fibers/electrical leads (410) of modified Hulvershom is fully capable of including the wireless interface (communication unit (185)), since the modified second end exits the probe's coupling structure/ hub as seen in Figs. I and 5 in Hendriks) and the pressure sensor is powered by the device (the sensing elements (210) are fully capable of being powered by power source (190) of the AECD (104)).
Regarding Claim 40, Hulvershom as modified, in the embodiment of Figs. 2A,2G, and 4A-B, discloses the system according to claim 38, and further discloses wherein the device includes an alarm system configured to emit an acoustic and/or audio and/or video signal when the pressure value is above or below a predetermined threshold (column 37, lines 19-40).
Regarding Claim 41, Hulvershom as modified, in the embodiment of Figs. 2A,2G, and 4A-B, discloses the system according to claim 38, and further discloses wherein the device
(104) includes a user interface (LCD (182)) to display the pressure value and/or a pressure
curve in real-time (column 14, lines 29-38).
Regarding Claim 42, Hulvershom as modified, in the embodiment of Figs. 2A,2G, and 4A-B, discloses the system according to claim 38, and further discloses wherein the device
(104) includes a wireless interface adapted to be connected to a portable device or to a PC
(90) to transmit at least the pressure value (column 21, lines 25-34) (A remote or external end of the sensing guidewire 400 can be coupled to a remote or external computer system or medical device 90, 92; column 22, lines 5-7).
Regarding Claim 43, Hulvershom as modified, in the embodiment of Figs. 2A,2G, and 4A-B, discloses the system according to claim 38, and further discloses wherein the device
(104) stores a plurality of pressure values detected by the sensor during an injection at corresponding injection times (column 16, lines 39-46), and a program to build a profile of pressures associated to the injection (column 13, lines 10-16), the profile being representable as a curve on a display (LCD (182)) (column 14, lines 29-38).
Regarding Claim 47, Hulvershom as modified, in the embodiment of Figs. 2A,2G, and 4A-B, discloses the system according to claim 38 and further discloses including a syringe
(50) adapted to be connected or connected to said needle (Figs.2A and 2E).
Regarding Claim 48, Hulvershom as modified, in the embodiment of Figs. 2A,2G, and 4A-B, discloses the system according to claim 28, wherein the fluid flows through the inner volume of the hub (In another embodiment, the probe's shaft 202 can include a conduit therethrough to facilitate such fluid communication. In an embodiment in which the probe's shaft is substantially hollow or includes a conduit, a bodily fluid can flow or be drawn into the
AECD 100, 102, 104 for sensing or analysis, and/or into a syringe 50 that is coupled to the AECD 100, 102, 104; columns 20 (lines 65-67)- 21 (lines 1-4)) and at least the portion of the cable in the needle is substantially rigid.
Hulvershorn, in the combination of embodiment of Figs. 2A,2G, and 4A-B, and 5B, does not appear to disclose wherein at least the portion of the cable in the needle is substantially rigid.
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to make at least the first portion of the cable within the lumen of the needle substantially rigid, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 49 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn et al. (U.S. Patent No. 9888881), hereinafter Hulvershorn, and further in view of Hendriks et al. ( U.S. Publication No. 20140121538), hereinafter Hendriks.
Regarding Claim 49, Hulvershom discloses a needle assembly for a syringe, comprising: a needle (needle 20; Figs. 2A,2G, and 4A-B) having a proximal end region, a distal end region, a tip (tip/distal segment (204)) at the distal end region configured to penetrate a body tissue during usage of the syringe (columns 20 (lines 64-67)- 21 (lines 1-4)), and a shaft (probe's shaft (202)) within the needle including a lumen (conduit) of space delimited by a continuous surface of an inner wall of the shaft;
a hub (probe sensing fitting (208)) having a hub distal end region secured to the proximal end region of the needle, a hub proximal end region defining a port (see below) configured to attach to the syringe or a tube (columns 20 (lines 64-67)- 21 (lines 1-4)), and a wall defining an inner volume of the hub and extending between the hub proximal end region and the hub distal end region (see below);
a pressure sensor (sensing elements (210)) (the sensing elements (210) can be a set of pressure sensors) (column 20, lines 30-35) in the needle configured to measure pressure of fluid in the shaft,
the pressure sensor and configured to transmit a pressure value sensed by the pressure sensor in the needle (the signal interface elements (228) transfer the signal between the set of sensing elements/pressure sensors (210) and the AECD (102; Fig. IC) (column 20, lines 52-55) wherein a processing unit (160; Fig. IC) in the AECD (102) determines a vascular pressure value (column 21, lines 41-44) and that the fluid drawn into or flow within the conduit in the probe's shaft (202) is subjected to sensing or analysis (columns 20 (lines 64-67)- 21 (lines 1-4)) ,
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Hulvershorn, in the embodiment of Figs. 2A,2G, and 4A-B, does not appear to disclose a cable having a first end region optically or electrically connected to the cable include a first portion extending in the lumen of the needle through the proximal end region of the needle and a second portion extending into the inner volume of the hub and exiting the hub through the wall of the hub between the hub distal end region and the hub proximal end region and does not exit the hub through the port, wherein the second portion of the cable is fixed to the wall of the hub and not to the port.
However, Hulvershorn, in the embodiment of Fig.SB, teaches it was known in the art to
have a cable (optical fibers/electrical leads (410)) having a first end region optically or electrically connected to the cable include a first portion (face/external surface of the optical fiber/electrical leads (410)), first end (end of the optical fibers (410) where the sensing devices (412) is located) extending in the lumen of the needle through the proximal end region of the needle and a second portion extending into the inner volume of the hub (the end that exits the probe's coupling structure (28) as seen in Fiug.5B) and exiting the hub through the wall of the hub between the hub distal end region and the hub proximal end region and does not exit the hub through the port, wherein the second portion of the cable is fixed to the wall of the hub and not to the port.
It would have been obvious to one having ordinary skill in the art before the effective
filing date of the claimed invention to have modified Hulvershom to incorporate a cable having a first end region optically or electrically connected to the cable include a first portion extending in the lumen of the needle through the proximal end region of the needle and a second portion extending into the inner volume of the hub and exiting the hub through the wall of the hub between the hub distal end region and the hub proximal end region and does not exit the hub through the port, wherein the second portion of the cable is fixed to the wall of the hub and not to the port. Doing so would maintain the pressure sensor within the needle in order to facilitate the sensing operation (column 21, lines 25-34).
Regarding Claim 50, Hulvershom as modified, in the embodiment of Figs. 2A,2G, and 4A-B, discloses the system according to claim 49, and Hulvershom further discloses the pressure sensor is maintained in a floating position within the lumen of the shaft (the sensing fitting (208) surrounds/encapsulates a portion of the set of sensing elements (210). The sensing elements (210) are floating within the probe' s shaft (202), since the probe sensing fitting (208) is a female luer lock fitting inserted within the shaft and the sensing elements is surrounded with the female luer lock fitting) (column 20, lines 40-45).
Hulvershorn, in the combination of embodiment of Figs. 2A,2G, and 4A-B, and 5B, does not appear to disclose wherein: at least the first portion of the cable within the lumen of the needle is substantially rigid; the pressure sensor not fixed to the continuous surface of the inner wall of the shaft of the needle and wherein the cable is configured to avoid fluctuation of the pressure sensor in the needle.
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to make at least the first portion of the cable within the lumen of the needle substantially rigid, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Hendriks teaches it was known in the art to have optical fibers (300; Fig.I) comprising a pressure sensor not fixed to the continuous surface of the inner wall of the shaft of the needle and wherein the cable is configured to avoid fluctuation of the pressure sensor in the needle (the Examiner notes modifying the exit of the modified cable (the optical fiber/electrical leads (410) of embodiment of Fig.SB of Hulvershom) through the hub is fully capable of avoiding fluctuation of the sensing elements within the shaft of Hulvershorn. Hendricks teaches a portion of the cable (portion between the front surfaces (310) and the end that exits the holder part (120)) is within the inner volume of the holder part (120) and the second end (end that exits a holder part (120)) of the optical fibers (300) crosses the surfaces of the holder part (120) (parag. [0066]); the Examiner notes filter system during detection with sensing elements to control variation, or fluctuation, to avoid overload).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hulvershom to incorporate the teachings of Hendriks to have the pressure sensor not fixed to the continuous surface of the inner wall of the shaft of the needle and wherein the cable is configured to avoid fluctuation of the pressure sensor in the needle. Doing so provides a filter system to avoid overloading sensors/detection system, as taught by Hendriks (see [0068]).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn (US 9888881), in particular the embodiment of Figs. 2A,2G, and 4A-B; in view of embodiment (Fig.SB) of Hulvershom, Hendriks (US 2014/0121538), Gorhan (US 9717434), and Cysyk (WO 2014/085806).
Regarding Claim 33, Hulvershom as modified, in the embodiment of Figs. 2A,2G, and 4A-B, discloses all the limitations of claim 28 above.
Hulvershorn, in the embodiment of Figs. 2A,2G, and 4A-B, does not appear to disclose a grid to protect the sensor in the needle wherein the grid being arranged between the tip of the needle and the sensor.
Cysyk teaches it was known in the art to have a silicone gel/oil (25; Fig.3) to isolate/protect a pressure sensor region (23) (parag. [0049]). The silicone oil (25) can be modified to be coupled between the sensing elements (210) and the inner surface of the shaft
(202) of the embodiment of Figs. 2A,2G, and 4A-B in Hulvershorn such that the silicone oil (25) is arranged between the tip (204) and the sensing elements (210).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hulvershom to incorporate the teachings of Cysyk to have a grid to protect the sensor in the needle wherein the grid being arranged between the tip of the needle and the sensor in order to protect the pressure sensor (parag. [0049]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn (US 9888881), in particular the embodiment of Figs. 2A,2G, and 4A-B; in view of embodiment (Fig.SB) of Hulvershom, Hendriks (US 2014/0121538), Gorhan (US 9717434), and Reich (US 6057911).
Regarding Claim 37, Hulvershom as modified, in the embodiment of Figs. 2A,2G, and 4A-B, discloses all the limitations of claim 36.
Hulvershorn, in the embodiment of Figs. 2A,2G, and 4A-B, does not appear to disclose the pressure sensor is a Fabry-Perot optical fibre sensor.
Reich teaches it was known in the art to have a Fabry-Perot strain sensor (column 2, lines
16-21).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hulvershom to incorporate the teachings of Reich to have a Fabry-Perot optical fibre sensor in order to measure the absolute strain/pressure (column 2, lines 16-21).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn (US 9888881), in particular the embodiment of Figs. 2A,2G, and 4A-B; in view of embodiment (Fig.SB) of Hulvershom, Hendriks (US 2014/0121538), Gorhan (US 9717434), and Norkunas (WO 2012/040543).
Regarding Claim 44, Hulvershom as modified, in the embodiment of Figs. 2A,2G, and 4A-B, discloses all the limitations of claim 38 above.
Hulvershorn, in the embodiment of Figs. 2A,2G, and 4A-B, does not appear to disclose a nerve stimulator to stimulate a nerve for an optimal positioning of the tip of needle.
Norkunas teaches it was known in the art to have a nerve stimulator (102; Fig. I) to place the needle into the desired area (parag. [0071]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hulvershom to incorporate the teachings of Norkunas to have a nerve stimulator in order to control the output of the needle to place the needle in the desired position (parag. [0071]).
Claims 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn (US 9888881), in particular the embodiment of Figs. 2A,2G, and 4A-B; in view of embodiment (Fig.SB) of Hulvershom, Hendriks (US 2014/0121538), Gorhan (US 9717434), Norkunas (WO 2012/040543), and Galindo (US 4411657).
Regarding Claim 45, Hulvershom as modified, in the embodiment of Figs. 2A,2G, and 4A-B, discloses the system according to claim 44, and Norkunas further teaches a generator (controller (114)) of electrical pulses (put current down) to deliver said pulses to the nerve (parag. [0081]).
Hulvershorn, in the embodiment of Figs. 2A,2G, and 4A-B, does not appear to disclose an electrode of the nerve stimulator is the needle wherein the electrode is electrically connected to a generator.
Galindo teaches it was known in the art to have an electrode needle. The needle/electrode is fully capable of being connected to the controller (114) (generator) of modified Hulvershom, since the controller (114) in Norkunas is connected to the needle housing (106) (Fig. I).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hulvershom to incorporate the teachings of Galindo to have an electrode of a nerve stimulator is the needle wherein the electrode is electrically connected to a generator in order to perform precise injection of local anesthetic solution (column 4, lines 42-44).
Regarding Claim 46, Hulvershom as modified, in the embodiment of Figs. 2A,2G, and 4A-B, discloses the system according to claim 45, and Norkunas further teaches wherein the generator (115) is included in said device (the controller (114) is located inside the device as seen in Fig. I).
Response to Arguments
Applicant's arguments filed 01/28/2026 regarding claim 28 have been fully considered but they are not persuasive.
In regards to the Applicant’s argument that the references don’t demonstrate wherein the cable is fixed in the wall of the hub and not the port and exits the hub and not the port.
This is not persuasive for the following reasons.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to change the location of the cable portion along the wall or the port, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Further, Hendriks discloses optical fibers 300 comprising a second end (end that exits a holder part 120) that exits from the holder part 120 through a wall of the holder part 120 and not through connector 130. The optical fibers 300 are fixed to the wall and not through the connector 130 as seen in Figs. 1 and 5. Also, Hendricks discloses a portion of the cable (portion between the front surfaces 310)and the end that exits the holder part 120) is within the inner volume of the holder part 120 and the second end (end that exits a holder part 120) of the optical fibers 300 crosses the surfaces of the holder part 120 (parag. [0066]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The
examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by
telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner, Art Unit 3783
08/26/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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