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 .
Notice of Amendment
In response to the amendment filed on 1/5/2026, amended claims 1, 3-4, 13, 15-16, and 18-19, cancelled claims 2, 14, and 17, and new claims 21-22 are acknowledged. Claims 1, 3-13, 15-16, and 18-22 are currently pending. The following new and reiterated grounds of rejection are set forth:
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-6, 12-13, 15-16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwach et al. (US Publication No. 2008/0221519 A1) (previously cited), further in view of Haim et al. (US Publication No. 2006/0184029 A1) (cited by Applicant).
Regarding claim 1, Schwach et al. discloses a medical device for assisting in a puncture operation on a human body, comprising:
an imaging unit (108) configured to acquire a cross-sectional image of a human body (see [0053] – “The acquisition module 108 is adapted to acquire optical, opto-acoustic or acoustic data from the tissue 106 and the blood vessel 102 that allows to classify at least one blood vessel parameter, such as location of the blood vessel, diameter of the blood vessel, size of the blood vessel, depth underneath the surface of the skin 104, geometry of the blood vessel, blood flow or similar parameters”);
a laser unit (17, 18) configured to emit laser light and project a marker onto a skin surface of the human body (see [0028] – “As an example, the puncture location can be marked by a cross or another figure, and the course of the vessel can be visualized by an arrow or a line. Furthermore, the angle of the cannula with respect to the skin can be indicated as well. The projection means may include a tiltable mirror reflecting the light emitted by the light source. The light can be laser light, e.g. a laser pointer, or the light of a light-emitting diode. The light is preferably green light, as green light is easily visible on all types of skin, i.e. on light skin as well as on dark skin” and [0064] – “As can be derived from FIG. 6, the puncture system 100 comprises a laser 17 and a projection means 18, the latter comprising a tiltable mirror, to project light onto the puncture location 124”); and
a controller (112) configured to:
determine a first distance from the imaging unit to a blood vessel and a diameter of the blood vessel using the cross-sectional image acquired by the imaging unit (see Figure 6 and [0053] – “The acquisition module 108 is adapted to acquire optical, opto-acoustic or acoustic data from the tissue 106 and the blood vessel 102 that allows to classify at least one blood vessel parameter, such as location of the blood vessel, diameter of the blood vessel, size of the blood vessel, depth underneath the surface of the skin 104, geometry of the blood vessel, blood flow or similar parameters”),
determine a position of a puncture point on the skin surface with respect to the imaging unit based on the determined first distance (see Figure 6 and [0053] – “The acquisition module 108 is adapted to acquire optical, opto-acoustic or acoustic data from the tissue 106 and the blood vessel 102 that allows to classify at least one blood vessel parameter, such as location of the blood vessel, diameter of the blood vessel, size of the blood vessel, depth underneath the surface of the skin 104, geometry of the blood vessel, blood flow or similar parameters”), and
control the laser unit to project onto the skin surface a marker including a point indicating the puncture point at the determined position thereof (see [0028] – “As an example, the puncture location can be marked by a cross or another figure, and the course of the vessel can be visualized by an arrow or a line. Furthermore, the angle of the cannula with respect to the skin can be indicated as well. The projection means may include a tiltable mirror reflecting the light emitted by the light source. The light can be laser light, e.g. a laser pointer, or the light of a light-emitting diode. The light is preferably green light, as green light is easily visible on all types of skin, i.e. on light skin as well as on dark skin” and [0064] – “As can be derived from FIG. 6, the puncture system 100 comprises a laser 17 and a projection means 18, the latter comprising a tiltable mirror, to project light onto the puncture location 124”).
It is noted Schwach et al. does not specifically teach the marker including a first line indicating the determined diameter of the blood vessel. However, Haim et al. teaches the marker including a point indicating the puncture point at the determined position thereof, and a first line (809) indicating the determined diameter of the blood vessel (see Figure 8B and [0047] – “Different arrows (808 and 809) indicate visually the parameters of the blood vessel (702) (diameter and depth accordantly)” and [0048] – “After reaching the exact position over the selected part of a blood vessel, the ultrasonic probe (103) is attached to the surface (614) using elastic supported arms (506). A pointing device (502) emits a laser beam (615) to indicate the vascular access optimal insertion point (616)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Schwach et al. to include the marker including a first line indicating the determined diameter of the blood vessel, as disclosed in Haim et al., so as to enable the marking of the best possible option of entrance to the blood vessel, making an accurate and precise procedure like vascular puncture possible (see Haim et al.: [0038]).
Regarding claim 3, Haim et al. teaches the controller is configured to determine a puncture depth (808) from the skin surface using the cross-sectional image, and the marker further indicates the determined puncture depth (see Figure 8B and [0047] – “Different arrows (808 and 809) indicate visually the parameters of the blood vessel (702) (diameter and depth accordantly)”).
Regarding claim 4, Haim et al. teaches the marker includes a second line, a length or shape of which indicates the puncture depth (see Figure 8B and [0047] – “Different arrows (808 and 809) indicate visually the parameters of the blood vessel (702) (diameter and depth accordantly)”).
Regarding claim 5, Schwach et al. discloses the controller is configured to determine a puncture direction from the puncture point to the blood vessel, and the marker further indicates the determined puncture direction (see [0058] – “Also, the puncture location may be determined with respect to a smallest possible depth of the blood vessel 102 underneath the surface of the skin 104. Additionally, the control unit may also determine the insertion direction 120 specifying at what angle .alpha. 119 the cannula 117 has to be introduced into the skin 104 and the tissue 106” and [0059] – “As can be derived from FIG. 6, the insertion position specifies a position as well as an alignment or direction of the cannula 117 from which the cannula 117 has to be shifted along the insertion direction, i.e. the direction coinciding with the longitudinal direction of the cannula, in order to hit the blood vessel at the determined puncture location with its distal end”).
Regarding claim 6, Schwach et al. discloses the claimed invention except one end of the marker corresponding to a distal side of the human body is thinner than the other end of the marker. It would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to construct the marker to have one end corresponding to a distal side of the human body be thinner than the other end of the marker, since applicant has not disclosed that such solves any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of projecting the blood vessel location on the skin. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding claim 12, Schwach et al. discloses the controller is configured to determine a position of a particular part of the blood vessel in the cross-sectional image, and determine a position of the blood vessel with respect to the imaging unit using the determined position of the particular part (see [0025] – “The location determining means carry out measurements by using the probe mentioned above, and the processing means, e.g. a computational entity and software, analyse the measurement values accordingly. The processing means may visualize the result on a screen, for example as a 2D image or a 3D image showing a blood vessel”), and
the controller determines a distance from the imaging unit to the determined position of the particular part as the first distance (see [0058] – “For instance, the optimization procedure that is typically performed by means of the processing unit of the control unit 112 may specify, that a puncture location must not be in the vicinity of a branch or junction of a blood vessel 102. Further, a puncture location may require a certain diameter of the blood vessel 102. Also, the puncture location may be determined with respect to a smallest possible depth of the blood vessel 102 underneath the surface of the skin 104”).
Regarding claim 13, Schwach et al. discloses a medical device for assisting in a puncture operation on a human body, comprising:
a probe body (2) extending along a first direction and including a bottom surface, the probe body further including an extension portion that extends from the probe body toward a second direction crossing the first direction (see Figures 1-2 and [0049] – “The attachment of the probe holder 2 to the arm 7 of a patient is shown in FIG. 2. The probe holder 2 rests on the strap 8, where the rails are not shown for simplicity. The probe 4 is on top of the probe holder 2 and scans to find blood vessels such as artery 22 or vein 23”);
an imaging unit (108) disposed along the bottom surface of the probe body and configured to acquire a cross-sectional image of a human body (see [0053] – “The acquisition module 108 is adapted to acquire optical, opto-acoustic or acoustic data from the tissue 106 and the blood vessel 102 that allows to classify at least one blood vessel parameter, such as location of the blood vessel, diameter of the blood vessel, size of the blood vessel, depth underneath the surface of the skin 104, geometry of the blood vessel, blood flow or similar parameters”);
a laser unit (17, 18) disposed at an end of the extension portion in the second direction, and configured to project a marker onto a skin surface of the human body (see [0028] – “As an example, the puncture location can be marked by a cross or another figure, and the course of the vessel can be visualized by an arrow or a line. Furthermore, the angle of the cannula with respect to the skin can be indicated as well. The projection means may include a tiltable mirror reflecting the light emitted by the light source. The light can be laser light, e.g. a laser pointer, or the light of a light-emitting diode. The light is preferably green light, as green light is easily visible on all types of skin, i.e. on light skin as well as on dark skin” and [0064] – “As can be derived from FIG. 6, the puncture system 100 comprises a laser 17 and a projection means 18, the latter comprising a tiltable mirror, to project light onto the puncture location 124”); and
a controller (112) configured to:
determine a position of a puncture point on the skin surface and a diameter of a blood vessel using the cross-sectional image acquired by the imaging unit (see Figure 6 and [0053] – “The acquisition module 108 is adapted to acquire optical, opto-acoustic or acoustic data from the tissue 106 and the blood vessel 102 that allows to classify at least one blood vessel parameter, such as location of the blood vessel, diameter of the blood vessel, size of the blood vessel, depth underneath the surface of the skin 104, geometry of the blood vessel, blood flow or similar parameters”), and
control the laser unit to project onto the skin surface a marker including a point indicating the puncture point at the determined position thereof (see [0028] – “As an example, the puncture location can be marked by a cross or another figure, and the course of the vessel can be visualized by an arrow or a line. Furthermore, the angle of the cannula with respect to the skin can be indicated as well. The projection means may include a tiltable mirror reflecting the light emitted by the light source. The light can be laser light, e.g. a laser pointer, or the light of a light-emitting diode. The light is preferably green light, as green light is easily visible on all types of skin, i.e. on light skin as well as on dark skin” and [0064] – “As can be derived from FIG. 6, the puncture system 100 comprises a laser 17 and a projection means 18, the latter comprising a tiltable mirror, to project light onto the puncture location 124”).
It is noted Schwach et al. does not specifically teach the marker including a first line indicating the determined diameter of the blood vessel. However, Haim et al. teaches the marker including a point indicating the puncture point at the determined position thereof, and a first line (809) indicating the determined diameter of the blood vessel (see Figure 8B and [0047] – “Different arrows (808 and 809) indicate visually the parameters of the blood vessel (702) (diameter and depth accordantly)” and [0048] – “After reaching the exact position over the selected part of a blood vessel, the ultrasonic probe (103) is attached to the surface (614) using elastic supported arms (506). A pointing device (502) emits a laser beam (615) to indicate the vascular access optimal insertion point (616)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Schwach et al. to include the marker including a first line indicating the determined diameter of the blood vessel, as disclosed in Haim et al., so as to enable the marking of the best possible option of entrance to the blood vessel, making an accurate and precise procedure like vascular puncture possible (see Haim et al.: [0038]).
Regarding claim 15, Haim et al. teaches the controller is configured to determine a puncture depth (808) from the skin surface using the cross-sectional image, and the marker further indicates the determined puncture depth (see Figure 8B and [0047] – “Different arrows (808 and 809) indicate visually the parameters of the blood vessel (702) (diameter and depth accordantly)”).
Regarding claim 16, Schwach et al. discloses a method for assisting in a puncture operation on a human body using a medical device that includes:
an imaging unit (108) configured to acquire a cross-sectional image of a human body (see [0053] – “The acquisition module 108 is adapted to acquire optical, opto-acoustic or acoustic data from the tissue 106 and the blood vessel 102 that allows to classify at least one blood vessel parameter, such as location of the blood vessel, diameter of the blood vessel, size of the blood vessel, depth underneath the surface of the skin 104, geometry of the blood vessel, blood flow or similar parameters”), and
a laser unit (17, 18) configured to emit laser light and project a marker onto a skin surface of the human body (see [0028] – “As an example, the puncture location can be marked by a cross or another figure, and the course of the vessel can be visualized by an arrow or a line. Furthermore, the angle of the cannula with respect to the skin can be indicated as well. The projection means may include a tiltable mirror reflecting the light emitted by the light source. The light can be laser light, e.g. a laser pointer, or the light of a light-emitting diode. The light is preferably green light, as green light is easily visible on all types of skin, i.e. on light skin as well as on dark skin” and [0064] – “As can be derived from FIG. 6, the puncture system 100 comprises a laser 17 and a projection means 18, the latter comprising a tiltable mirror, to project light onto the puncture location 124”), the method comprising:
determining a first distance from the imaging unit to a blood vessel and a diameter of the blood vessel using the cross-sectional image acquired by the imaging unit (see Figure 6 and [0053] – “The acquisition module 108 is adapted to acquire optical, opto-acoustic or acoustic data from the tissue 106 and the blood vessel 102 that allows to classify at least one blood vessel parameter, such as location of the blood vessel, diameter of the blood vessel, size of the blood vessel, depth underneath the surface of the skin 104, geometry of the blood vessel, blood flow or similar parameters”);
determining a position of a puncture point on the skin surface with respect to the imaging unit based on the determined first distance (see Figure 6 and [0053] – “The acquisition module 108 is adapted to acquire optical, opto-acoustic or acoustic data from the tissue 106 and the blood vessel 102 that allows to classify at least one blood vessel parameter, such as location of the blood vessel, diameter of the blood vessel, size of the blood vessel, depth underneath the surface of the skin 104, geometry of the blood vessel, blood flow or similar parameters”); and
controlling the laser unit to project onto the skin surface a marker including a point indicating the puncture point at the determined position thereof (see [0028] – “As an example, the puncture location can be marked by a cross or another figure, and the course of the vessel can be visualized by an arrow or a line. Furthermore, the angle of the cannula with respect to the skin can be indicated as well. The projection means may include a tiltable mirror reflecting the light emitted by the light source. The light can be laser light, e.g. a laser pointer, or the light of a light-emitting diode. The light is preferably green light, as green light is easily visible on all types of skin, i.e. on light skin as well as on dark skin” and [0064] – “As can be derived from FIG. 6, the puncture system 100 comprises a laser 17 and a projection means 18, the latter comprising a tiltable mirror, to project light onto the puncture location 124”).
It is noted Schwach et al. does not specifically teach the marker including a first line indicating the determined diameter of the blood vessel. However, Haim et al. teaches the marker including a point indicating the puncture point at the determined position thereof, and a first line (809) indicating the determined diameter of the blood vessel (see Figure 8B and [0047] – “Different arrows (808 and 809) indicate visually the parameters of the blood vessel (702) (diameter and depth accordantly)” and [0048] – “After reaching the exact position over the selected part of a blood vessel, the ultrasonic probe (103) is attached to the surface (614) using elastic supported arms (506). A pointing device (502) emits a laser beam (615) to indicate the vascular access optimal insertion point (616)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Schwach et al. to include the marker including a first line indicating the determined diameter of the blood vessel, as disclosed in Haim et al., so as to enable the marking of the best possible option of entrance to the blood vessel, making an accurate and precise procedure like vascular puncture possible (see Haim et al.: [0038]).
Regarding claim 18, Haim et al. teaches determining a puncture depth (808) from the skin surface using the cross-sectional image, wherein the marker further indicates the determined puncture depth (see Figure 8B and [0047] – “Different arrows (808 and 809) indicate visually the parameters of the blood vessel (702) (diameter and depth accordantly)”).
Regarding claim 19, Haim et al. teaches the marker includes a second line, a length or shape of which indicates the puncture depth (see Figure 8B and [0047] – “Different arrows (808 and 809) indicate visually the parameters of the blood vessel (702) (diameter and depth accordantly)”).
Regarding claim 20, Schwach et al. discloses determining a puncture direction from the puncture point to the blood vessel, wherein the marker further indicates the determined puncture direction (see [0058] – “Also, the puncture location may be determined with respect to a smallest possible depth of the blood vessel 102 underneath the surface of the skin 104. Additionally, the control unit may also determine the insertion direction 120 specifying at what angle .alpha. 119 the cannula 117 has to be introduced into the skin 104 and the tissue 106” and [0059] – “As can be derived from FIG. 6, the insertion position specifies a position as well as an alignment or direction of the cannula 117 from which the cannula 117 has to be shifted along the insertion direction, i.e. the direction coinciding with the longitudinal direction of the cannula, in order to hit the blood vessel at the determined puncture location with its distal end”).
Claim(s) 7 and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwach et al. and Haim et al., further in view of Yasui (US Patent No. 8,467,855 B2) (previously cited).
Regarding claim 7, it is noted Schwach et al. does not specifically teach the controller is configured to determine a center of gravity of the blood vessel in the cross-sectional image, and determine a position of the blood vessel with respect to the imaging unit using the determined center of gravity, the controller determines a distance from the imaging unit to the determined position of the blood vessel as the first distance, and the controller determines, as the position of the puncture point, a point at which the skin surface intersects with a line extending from the position of the blood vessel toward a direction that is inclined at a predetermined angle with respect to a direction perpendicular to the skin surface. However, Yasui teaches the controller is configured to determine a center of gravity of the blood vessel in the cross-sectional image, and determine a position of the blood vessel with respect to the imaging unit using the determined center of gravity (see Figures 2-3 and col. 5, lines 41-45 – “Hence, the same location 88 is defined as a part of the blood vessel in the planar image 5, which is located at the same X coordinate as the X coordinate of the intersection 8 of the extended line 11 of the needle 10 with the blood vessel 8 in the lateral image 6”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Schwach et al. to include the controller is configured to determine a center of gravity of the blood vessel in the cross-sectional image, and determine a position of the blood vessel with respect to the imaging unit using the determined center of gravity, as disclosed in Yasui, so as to allow the recognition of the three-dimensional relationship between the blood vessel and needle (see Yasui: Abstract).
Schwach et al. then teaches the controller determines a distance from the imaging unit to the determined position (124) of the blood vessel as the first distance, and the controller determines, as the position of the puncture point, a point at which the skin surface intersects with a line (126) extending from the position of the blood vessel toward a direction that is inclined at a predetermined angle (119) with respect to a direction perpendicular to the skin surface (see Figure 6 and [0057] – “The control unit 112 serves to process the blood vessel parameters in order to find and determine a puncture location of the blood vessel 102 that is ideally suited for an insertion of the cannula 117. In a basic embodiment this puncture location may be determined with respect to location and course of the blood vessel 102. More sophisticated implementations further account for the vessel geometry in the vicinity of an intended puncture location as well as vessel diameter and depth underneath the surface of the skin 104” and [0058] – “Also, the puncture location may be determined with respect to a smallest possible depth of the blood vessel 102 underneath the surface of the skin 104. Additionally, the control unit may also determine the insertion direction 120 specifying at what angle .alpha. 119 the cannula 117 has to be introduced into the skin 104 and the tissue 106”).
Regarding claim 9, Schwach et al. teaches a probe body including a bottom surface along which the imaging unit is disposed at a center of the bottom surface (see Figure 1 and [0049] – “The attachment of the probe holder 2 to the arm 7 of a patient is shown in FIG. 2. The probe holder 2 rests on the strap 8, where the rails are not shown for simplicity. The probe 4 is on top of the probe holder 2 and scans to find blood vessels such as artery 22 or vein 23”). It is noted Schwach et al. does not specifically teach the controller is configured to determine a center of gravity of the blood vessel in the cross-sectional image, and determine a position of the blood vessel with respect to the imaging unit using the determined center of gravity. However, Yasui teaches the controller is configured to determine a center of gravity of the blood vessel in the cross-sectional image, and determine a position of the blood vessel with respect to the imaging unit using the determined center of gravity (see Figures 2-3 and col. 5, lines 41-45 – “Hence, the same location 88 is defined as a part of the blood vessel in the planar image 5, which is located at the same X coordinate as the X coordinate of the intersection 8 of the extended line 11 of the needle 10 with the blood vessel 8 in the lateral image 6”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Schwach et al. to include the controller is configured to determine a center of gravity of the blood vessel in the cross-sectional image, and determine a position of the blood vessel with respect to the imaging unit using the determined center of gravity, as disclosed in Yasui, so as to allow the recognition of the three-dimensional relationship between the blood vessel and needle (see Yasui: Abstract).
Schwach et al. then teaches the controller determines, as the position of the puncture point, a point at which the skin surface intersects a first line (126) extending from the position (124) of the blood vessel to one end of the bottom surface of the probe body (see Figure 6 and [0057] – “The control unit 112 serves to process the blood vessel parameters in order to find and determine a puncture location of the blood vessel 102 that is ideally suited for an insertion of the cannula 117. In a basic embodiment this puncture location may be determined with respect to location and course of the blood vessel 102. More sophisticated implementations further account for the vessel geometry in the vicinity of an intended puncture location as well as vessel diameter and depth underneath the surface of the skin 104” and [0058] – “Also, the puncture location may be determined with respect to a smallest possible depth of the blood vessel 102 underneath the surface of the skin 104. Additionally, the control unit may also determine the insertion direction 120 specifying at what angle .alpha. 119 the cannula 117 has to be introduced into the skin 104 and the tissue 106”).
Regarding claim 10, Schwach et al. teaches the controller is configured to determine an angle (119) formed by the first line and a direction perpendicular to the skin surface as a puncture angle (see Figure 6 and [0058] – “Also, the puncture location may be determined with respect to a smallest possible depth of the blood vessel 102 underneath the surface of the skin 104. Additionally, the control unit may also determine the insertion direction 120 specifying at what angle .alpha. 119 the cannula 117 has to be introduced into the skin 104 and the tissue 106”) but does not specifically teach the marker indicates the puncture angle. However, Yasui teaches the marker further indicates the puncture angle (see Figures 2-3 and col. 4, lines 41-49 – “The above-described syringe needle guiding apparatus is characterized in that the distance from the tip of the needle to the mark and the angle of the needle with respect to the blood vessel are indicated by a figure having the mark as its center, and the figure is a depth-wise virtual image in which a change of the distance along with movement of the needle is expressed by a change in size of the figure and a change of the angle along with movement of the needle is expressed by a change in shape of the figure” and col. 5, lines 49-54 – “This total image 7 indicates, with an ellipse, a distance from the needle tip to the insertion target 88 as well as an angle at which the extended line 11 of the needle intersects the blood vessel 9 in the lateral image 6. Although an ellipse is used in Example 1, the shape is not limited and may be a rectangle or a star”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Schwach et al. to include the marker indicates the puncture angle, as disclosed in Yasui, so as to allow the recognition of the three-dimensional relationship between the blood vessel and needle (see Yasui: Abstract).
Regarding claim 11, Schwach et al. teaches the controller is configured to determine a second distance from the position of the blood vessel to the position of the puncture point as a puncture depth (see Figure 6 and [0053] – “The acquisition module 108 is adapted to acquire optical, opto-acoustic or acoustic data from the tissue 106 and the blood vessel 102 that allows to classify at least one blood vessel parameter, such as location of the blood vessel, diameter of the blood vessel, size of the blood vessel, depth underneath the surface of the skin 104, geometry of the blood vessel, blood flow or similar parameters”) but does not specifically teach the marker further indicates the puncture depth. However, Yasui teaches the marker further indicates the puncture depth (see Figures 2-3 and col. 4, lines 41-49 – “The above-described syringe needle guiding apparatus is characterized in that the distance from the tip of the needle to the mark and the angle of the needle with respect to the blood vessel are indicated by a figure having the mark as its center, and the figure is a depth-wise virtual image in which a change of the distance along with movement of the needle is expressed by a change in size of the figure and a change of the angle along with movement of the needle is expressed by a change in shape of the figure” and col. 5, lines 49-54 – “This total image 7 indicates, with an ellipse, a distance from the needle tip to the insertion target 88 as well as an angle at which the extended line 11 of the needle intersects the blood vessel 9 in the lateral image 6. Although an ellipse is used in Example 1, the shape is not limited and may be a rectangle or a star”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Schwach et al. to include the marker indicates the puncture depth, as disclosed in Yasui, so as to allow the recognition of the three-dimensional relationship between the blood vessel and needle (see Yasui: Abstract).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwach et al. and Haim et al., further in view of Buljubasic (US Patent No. 10,806,486 B2) (previously cited).
Regarding claim 8, it is noted Schwach et al. does not specifically teach a probe body extending along a first direction and including a bottom surface along which the imaging unit is disposed, the probe body further including an extension portion that extends along a second direction crossing the first direction and includes the laser unit, wherein the laser unit projects the marker along a direction that is inclined at a predetermined angle with respect to the first direction. However, Buljubasic teaches a probe body (105) extending along a first direction and including a bottom surface along which the imaging unit (110, 115) is disposed (see Figures 1 and 4-5 and [0041] – “The ultrasonic transducer arrays 110, 115 permit a user to visualize a target structure 20 beneath a surface 10. For example, the ultrasound probe 100 may be placed on a patient's skin so as to emit the planar ultrasonic beams 111, 116 through the skin toward a vein beneath the skin”), the probe body further including an extension portion that extends along a second direction crossing the first direction and includes the laser unit (125) (see [0038] – “The first light source 120 and the second light source 125 are coupled to the housing 105. Each of the light sources may be a laser or any other light source capable of emitting a light line within a plane”), wherein the laser unit projects the marker along a direction that is inclined at a predetermined angle with respect to the first direction (see Figures 7-13 and [0047] – “Similarly, the third plane 127 can be configured to define an angle of entry 129 for the instrument 30, and the intersection 130 between the second light line 126 and the first light line 121 can define a point of entry 130 for the instrument. As discussed above, the second light line is projected within the third plane, which intersects the second plane 117 of the second planar ultrasonic beam 116 at an oblique angle 128. If the third plane intersects the second plane substantially at the point where the second plane intersects the target structure 20, the third plane will define an angle of entry for the instrument 129”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Schwach et al. to include a probe body extending along a first direction and including a bottom surface along which the imaging unit is disposed, the probe body further including an extension portion that extends along a second direction crossing the first direction and includes the laser unit, wherein the laser unit projects the marker along a direction that is inclined at a predetermined angle with respect to the first direction, as disclosed in Buljubasic, so as to define an angle of entry and a point of entry for the instrument (see Buljubasic: [0047]).
Allowable Subject Matter
Claims 21-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record, singly and in combination, fails to teach the marker including all of the following features: a point indicating the puncture point at the determined position thereof, a first line having a length or shape indicating the determined diameter of the blood vessel, a second line having a length or shape indicating the puncture depth, and the first line crossing the second line.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Instead, Applicant’s arguments are directed to the newly added subject matter of the amended claims, which is addressed in the new grounds of rejection as outlined above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791