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
Applicant’s election without traverse of claims 1-20 in the reply filed on 07/30/2025 is acknowledged.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 10, 11, 13, 15-17 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of U.S. Patent No. US 12075989 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. See comparison chart below.
Instant application (18/667,392)
Reference Application (US 12075989 B2)
1. A needle guidance device, comprising:
a guide platform configured to removably couple to an ultrasound probe, the ultrasound probe having a length extending along a longitudinal axis of the ultrasound probe;
a guide tower extending from the guide platform; and
a needle holder device pivotably coupled to the guide tower, the needle holder device defining a central aperture therethrough configured to receive a puncture device, the needle holder device pivotably movable about an axis perpendicular to the longitudinal axis with respect to the guide tower to move the puncture device from a first path angle orientation of a plurality of path angle orientations within a plane including the longitudinal axis to a second path angle orientation of the plurality of path angle orientations within the plane different from the first path angle orientation.
1. A puncture device guide, comprising:
a guide platform configured to releasably attach to an ultrasound probe;
a guide tower slidingly coupled to the guide platform, wherein the guide tower is enabled to slide relative to the guide platform; and
a needle holder device removably coupled to the guide tower,
wherein the guide tower projects upwardly from the guide platform,
wherein the guide tower includes a single vertical guidance slot and a plurality of vertical attachment positions at a plurality of spaced vertical locations within the vertical guidance slot, each vertical attachment position of the plurality of vertical attachment positions for engaging the needle holder device at a corresponding vertical position within the vertical guidance slot,
wherein the needle holder device further comprises:
a body portion having a central aperture extending therethrough; and
a pair of engagement shoulders extending outwardly from the body portion, wherein each vertical attachment position in the guide tower comprises a pair of arcuately shaped needle holder device receiving cups positioned on opposite sides of the vertical guidance slot to define a vertical distance from the ultrasound probe, and wherein an arcuate shape of each the pair of arcuately shaped needle holder device receiving cups is configured to pivotably receive a corresponding engagement shoulder of the pair of engagement shoulders in the needle holder device and the needle holder device is pivotably movable within the pair of needle holder device receiving cups between a plurality of path angles.
3. The needle guidance device of claim 1, further comprising an adjustment knob operatively coupled to the needle holder device, the adjustment knob configured to secure the needle holder device at the first path angle orientation.
15. The puncture device guide of claim 1, further comprising:
an alignment plate adjustment knob,
wherein rotation of the alignment plate adjustment knob causes the alignment plate to engage the body portion of the needler holder device, to retain the needle holder device at a selected position.
10. The needle guidance device of claim 1, wherein the guide tower defines a central opening and the needle holder device is movably positioned with the central opening, the needle holder device movable within the central opening to adjust at least one of a path angle orientation or a path height position of the needle holder device in the plane.
1. A puncture device guide, comprising :
…
wherein the guide tower includes a single vertical guidance slot and a plurality of vertical attachment positions at a plurality of spaced vertical locations within the vertical guidance slot, each vertical attachment position of the plurality of vertical attachment positions for engaging the needle holder device at a corresponding vertical position within the vertical guidance slot,
11. The needle guidance device of claim 10, further comprising an adjustment knob operatively coupled to the needle holder device, the adjustment knob configured to secure the needle holder device at the at least one of the path angle orientation or the path height position.
15. The puncture device guide of claim 1, further comprising:
an alignment plate adjustment knob,
wherein rotation of the alignment plate adjustment knob causes the alignment plate to engage the body portion of the needler holder device, to retain the needle holder device at a selected position.
13. The needle guidance device of claim 1, wherein the guide tower defines a central opening, the needle holder device movable within the central opening to adjust at least one of a path angle orientation within the plane or a path height position of the needle holder device at a distance with respect to the guide platform within the plane.
1. A puncture device guide, comprising :
…
wherein the guide tower includes a single vertical guidance slot and a plurality of vertical attachment positions at a plurality of spaced vertical locations within the vertical guidance slot, each vertical attachment position of the plurality of vertical attachment positions for engaging the needle holder device at a corresponding vertical position within the vertical guidance slot,
15. (Original) The needle guidance device of claim 13, wherein the needle holder device is movable within the central opening between a first path height position of the needle holder device with respect to the guide platform and a second path height position of the needle holder device with respect to the guide platform.
1. A puncture device guide, comprising :
….
wherein the guide tower includes a single vertical guidance slot and a plurality of vertical attachment positions at a plurality of spaced vertical locations within the vertical guidance slot, each vertical attachment position of the plurality of vertical attachment positions for engaging the needle holder device at a corresponding vertical position within the vertical guidance slot
…
the pair of arcuately shaped needle holder device receiving cups is configured to pivotably receive a corresponding engagement shoulder of the pair of engagement shoulders in the needle holder device and the needle holder device is pivotably movable within the pair of needle holder device receiving cups between a plurality of path angles.
16. (Original) A needle guidance device, comprising:
a guide platform configured to removably couple to an ultrasound probe, the ultrasound probe having a length extending along a longitudinal axis of the ultrasound probe;
a guide tower extending from the guide platform; and
a needle holder device rotatably coupled to the guide tower, the needle holder device defining a central aperture therethrough configured to receive a puncture device, the needle holder device rotatably movable about a rotational axis perpendicular to the longitudinal axis with respect to the guide tower to move the puncture device from a first path angle orientation of a plurality of path angle orientations within a plane including the longitudinal axis to a second path angle orientation of the plurality of path angle orientations within the plane different from the first path angle orientation.
1. A puncture device guide, comprising:
a guide platform configured to releasably attach to an ultrasound probe;
a guide tower slidingly coupled to the guide platform, wherein the guide tower is enabled to slide relative to the guide platform; and
a needle holder device removably coupled to the guide tower,
wherein the guide tower projects upwardly from the guide platform,
wherein the guide tower includes a single vertical guidance slot and a plurality of vertical attachment positions at a plurality of spaced vertical locations within the vertical guidance slot, each vertical attachment position of the plurality of vertical attachment positions for engaging the needle holder device at a corresponding vertical position within the vertical guidance slot,
wherein the needle holder device further comprises:
a body portion having a central aperture extending therethrough; and
a pair of engagement shoulders extending outwardly from the body portion, wherein each vertical attachment position in the guide tower comprises a pair of arcuately shaped needle holder device receiving cups positioned on opposite sides of the vertical guidance slot to define a vertical distance from the ultrasound probe, and wherein an arcuate shape of each the pair of arcuately shaped needle holder device receiving cups is configured to pivotably receive a corresponding engagement shoulder of the pair of engagement shoulders in the needle holder device and the needle holder device is pivotably movable within the pair of needle holder device receiving cups between a plurality of path angles.
17. The needle guidance device of claim 16, wherein the needle holder device is positionable at a plurality of path height positions, each path height position of the plurality of path height positions located at a corresponding distance from a surface of the guide platform.
1. A puncture device guide, comprising :
….
wherein the guide tower includes a single vertical guidance slot and a plurality of vertical attachment positions at a plurality of spaced vertical locations within the vertical guidance slot, each vertical attachment position of the plurality of vertical attachment positions for engaging the needle holder device at a corresponding vertical position within the vertical guidance slot
…
the pair of arcuately shaped needle holder device receiving cups is configured to pivotably receive a corresponding engagement shoulder of the pair of engagement shoulders in the needle holder device and the needle holder device is pivotably movable within the pair of needle holder device receiving cups between a plurality of path angles.
19. A needle guidance device, comprising:
a guide platform configured to removably couple to an ultrasound probe, the ultrasound probe having a length extending along a longitudinal axis of the ultrasound probe;
a guide tower extending from the guide platform, the guide tower defining a central opening; and
a needle holder device movably positioned with the central opening to adjust at least one of a path angle orientation or a path height position of the needle holder device in a plane including the longitudinal axis, the needle holder device defining a central aperture extending therethrough from a proximal surface of the needle holder device to an opposite distal surface of the needle holder device and configured to receive a puncture device.
1. A puncture device guide, comprising:
a guide platform configured to releasably attach to an ultrasound probe;
a guide tower slidingly coupled to the guide platform, wherein the guide tower is enabled to slide relative to the guide platform; and
a needle holder device removably coupled to the guide tower,
wherein the guide tower projects upwardly from the guide platform,
wherein the guide tower includes a single vertical guidance slot and a plurality of vertical attachment positions at a plurality of spaced vertical locations within the vertical guidance slot, each vertical attachment position of the plurality of vertical attachment positions for engaging the needle holder device at a corresponding vertical position within the vertical guidance slot,
wherein the needle holder device further comprises:
a body portion having a central aperture extending therethrough; and
a pair of engagement shoulders extending outwardly from the body portion, wherein each vertical attachment position in the guide tower comprises a pair of arcuately shaped needle holder device receiving cups positioned on opposite sides of the vertical guidance slot to define a vertical distance from the ultrasound probe, and wherein an arcuate shape of each the pair of arcuately shaped needle holder device receiving cups is configured to pivotably receive a corresponding engagement shoulder of the pair of engagement shoulders in the needle holder device and the needle holder device is pivotably movable within the pair of needle holder device receiving cups between a plurality of path angles.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2,4-6, 8, 10, and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Allaway (US 20160022309 A1) in view of Orome (US 20120330159 A1).
Regarding claim 1, Allaway teaches a needle guidance device, comprising:
a guide platform (lower mount 2704 [0203]; [fig. 27] reproduced below) configured to removably couple to an ultrasound probe (The lower mount 2704 includes a probe coupling or fastening mechanism 2706 to couple the lower mount 2704 with a transrectal probe [0203]; fastening mechanism is inherently releasable, example disclosed in [0246]), the ultrasound probe having a length extending along a longitudinal axis of the ultrasound probe (ultrasound probe inherently has a length/longitudinal axis that goes down the length of the device, ultrasound probe shown in fig. 1);
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Fig. 27 of Allaway reproduced above
a guide tower (upper mount 2702 [0203]; [fig. 27]) extending from the guide platform (the rail 2764 may engage with a platform 2766 of the upper mount coupling mechanism 2714 of the lower mount 2704 so as to align the upper and lower mounts 2702, 2704 upon coupling together [0212]; guide tower 2704 extends from guide platform 2704 as shown in fig. 27); and
… the needle holder device (vertically extending member 2760 includes five needle receiving ports 2768 [0216]; [fig. 28] reproduced above) defining a central aperture therethrough configured to receive a puncture device (Each of the openings 2770 of the needle receiving ports 2768 are generally vertically aligned with each other and each includes a trajectory axis 2776 defining a trajectory of the access needle 2712 when positioned within the opening 2770 [0214]; [fig. 32a] reproduced below; the needle receiving port that is aligned is the central aperture as claimed).
Allaway, however does not teach a needle holder device pivotably coupled to the guide tower, and the needle holder device pivotably movable about an axis perpendicular to the longitudinal axis with respect to the guide tower to move the puncture device from a first path angle orientation of a plurality of path angle orientations within a plane including the longitudinal axis to a second path angle orientation of the plurality of path angle orientations within the plane different from the first path angle orientation.
Orome is considered analogous to the instant application as “Needle Guide with Selectable Aspects” is disclosed (title).
Orome teaches:
a needle holder device ( needle guide assembly 860; [520]) pivotably coupled to the guide tower (the needle guide assembly itself is pivotally attached to an ultrasound probe 850 via an arm 870 pivotally attached to the probe [0082];
the needle holder device pivotably movable about an axis perpendicular to the longitudinal axis (longitudinal axis and axis perpendicular to it is labeled below) with respect to the guide tower to move the puncture device from a first path angle orientation of a plurality of path angle orientations within a plane including the longitudinal axis to a second path angle orientation of the plurality of path angle orientations within the plane different from the first path angle orientation (This enables the needle 70 received by the guide channel 864 to be positioned in one of at least two positions: a first position wherein the needle 70 is disposed relatively far from the patient's skin, and a second position (caused by distal pivoting of the needle guide assembly arm 870) wherein the distal tip of the needle is positioned relatively close to the skin surface. The clinician can then distally advance the needle 70 as desired. [0082]; the needle can go across two path angles “position 1” and “position 2” shown below, ).
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Fig. 24 of Orome reproduced above with annotations
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Allaway to include a needle holder device pivotably coupled to the guide tower, and the needle holder device pivotably movable about an axis perpendicular to the longitudinal axis with respect to the guide tower to move the puncture device from a first path angle orientation of a plurality of path angle orientations within a plane including the longitudinal axis to a second path angle orientation of the plurality of path angle orientations within the plane different from the first path angle orientation, as taught by Orome. Doing so would facilitate proper placement of a needle into a patient so as to access a desired target at a particular subcutaneous depth, such as a vessel, for instance ([0040])
Regarding claim 2, modified Allaway teaches the needle guidance device of claim 1, as discussed above. Allaway further teaches wherein the needle holder device is lockable with respect to the guide tower to prevent movement of the needle holder device in a distal direction and an opposite proximal direction with respect to the guide tower (a proximal side 2800 of the needle receiving ports 2768 includes keyed features to lockingly engage the access needle 2712 such that it does not rotate once it is coupled with the port 2768 [0220]; the keyed ports limit the movement of the needle holder device such that it moves within the rails, i.e. prevents movement outside of the guide tower that is not within the rails).
Regarding claim 4, modified Allaway teaches the needle guidance device of claim 1, as discussed above. Allaway further teaches wherein the central aperture extends between a distal end of the needle holder device and a proximal end of the needle holder device, the central aperture configured to receive the puncture device and maintain the puncture device within the plane (That is, the rectangular member 2728 is aligned with the opening between the upper members 2784 and the lower tab members 2780, and the vertically extending side members 2732 are aligned with the channels 2794 between the inner surfaces 2792 of the upside-down U-shaped member 2790 of the displacement member 2710. Once aligned, the displacement member 2710 is displaced, moved, or translated into engagement with the guide member 2708 [0227]; central aperture 2410 extends between the proximal and distal end of the device, which contains the needle holder 2760 as shown in fig. 27 and 30).
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Fig. 30 of Allaway reproduced above
Regarding claim 5, Allaway teaches the needle guidance device of claim 1, as discussed above. Allaway further teaches wherein the puncture device is movably positioned within the central aperture to move in a distal direction and an opposite proximal direction with respect to the guide tower (Thus, when the access needle 2712 is coupled with the displacement member 2710, the access needle 2712 is also displaceable between the proximal end 2718 of the guide member 2708 to the distal end 2716 [0213]).
Regarding claim 6, modified Allaway teaches the needle guidance device of claim 1, as discussed above. Allaway further teaches wherein the needle holder device is positionable at a plurality of path height positions, each path height position of the plurality of path height positions located at a corresponding distance from the guide platform (Each needle receiving port 2768 includes an opening 2770 extending from a distal end 2772 to a proximal end 2774 of the displacement member 2710. Each of the openings 2770 of the needle receiving ports 2768 are generally vertically aligned with each other and each includes a trajectory axis 2776 defining a trajectory of the access needle 2712 when positioned within the opening 2770 [0214]).
Regarding claim 8, Allaway teaches the needle guidance device of claim 1, as discussed above. Allaway further teaches wherein the needle holder device is movable between a first path height position and a second path height position with respect to the guide platform (Each needle receiving port 2768 includes an opening 2770 extending from a distal end 2772 to a proximal end 2774 of the displacement member 2710. Each of the openings 2770 of the needle receiving ports 2768 are generally vertically aligned with each other and each includes a trajectory axis 2776 defining a trajectory of the access needle 2712 when positioned within the opening 2770 [0214]).
Regarding claim 10, modified Allaway teaches the needle guidance device of claim 1, as discussed above. Allaway, however, does not teach wherein the guide tower defines a central opening and the needle holder device is movably positioned with the central opening, the needle holder device movable within the central opening to adjust at least one of a path angle orientation or a path height position of the needle holder device in the plane.
Orome, however, teaches wherein the guide tower (22) defines a central opening and the needle holder device is movably positioned with the central opening (opening between rails 318), the needle holder device (314) movable within the central opening to adjust at least one of a path angle orientation or a path height position of the needle holder device in the plane (FIGS. 11A and 11B show a needle guide assembly 310 according to another embodiment, including a body 312 defining a cavity 322 for attachment to a probe, probe cap, or the like. A platform 314 including a slotted needle guide channel 320 is also included. In particular, the platform 314 includes a notched arm 316 that is slidably disposed between two arcuate rails 318 of the body 312. So configured, the platform 314 is slidable along the rails 318 to enable the insertion angle of the guide channel 320 to be modified as desired by the user so as to enable a needle inserted therein to intercept an imaged subcutaneous target, such as a vessel [0060]).
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Fig. 12A of Orome reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Allaway to include wherein the guide tower defines a central opening and the needle holder device is movably positioned with the central opening, the needle holder device movable within the central opening to adjust at least one of a path angle orientation or a path height position of the needle holder device in the plane, as taught by Orome. Doing so would enable the insertion angle of the guide channel 320 to be modified as desired by the user so as to enable a needle inserted therein to intercept an imaged subcutaneous target, such as a vessel, as suggested by Orome ([0060]).
Regarding claim 12, modified Allaway teaches the needle guidance device of claim 1, wherein the guide tower is movable with respect to the guide platform in a distal direction and an opposite proximal direction with respect to the guide platform. ((Thus, when the access needle 2712 is coupled with the displacement member 2710, the access needle 2712 is also displaceable between the proximal end 2718 of the guide member 2708 to the distal end 2716 [0213]).
Regarding claim 13, modified Allaway teaches the needle guidance device of claim 1, as discussed above. Allaway, however, does not teach, wherein the guide tower defines a central opening, the needle holder device movable within the central opening to adjust at least one of a path angle orientation within the plane or a path height position of the needle holder device at a distance with respect to the guide platform within the plane.
Orome, however, teaches, wherein the guide tower (22) defines a central opening (314), the needle holder device movable within the central opening to adjust at least one of a path angle orientation within the plane or a path height position of the needle holder device at a distance with respect to the guide platform within the plane ((FIGS. 11A and 11B show a needle guide assembly 310 according to another embodiment, including a body 312 defining a cavity 322 for attachment to a probe, probe cap, or the like. A platform 314 including a slotted needle guide channel 320 is also included. In particular, the platform 314 includes a notched arm 316 that is slidably disposed between two arcuate rails 318 of the body 312. So configured, the platform 314 is slidable along the rails 318 to enable the insertion angle of the guide channel 320 to be modified as desired by the user so as to enable a needle inserted therein to intercept an imaged subcutaneous target, such as a vessel [0060]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Allaway to include wherein the guide tower defines a central opening, the needle holder device movable within the central opening to adjust at least one of a path angle orientation within the plane or a path height position of the needle holder device at a distance with respect to the guide platform within the plane, as taught by Orome. Doing so would enable the insertion angle of the guide channel to be modified as desired by the user so as to enable a needle inserted therein to intercept an imaged subcutaneous target, such as a vessel, as suggested by Orome ([0060]).
Regarding claim 14, modified Allaway teaches the needle guidance device of claim 13, as discussed above. Allaway, however does not teach, wherein the needle holder device is movable within the central opening between the first path angle orientation and the second path angle orientation.
Orome, however teaches wherein the needle holder device is movable within the central opening between the first path angle orientation and the second path angle orientation (FIGS. 11A and 11B show a needle guide assembly 310 according to another embodiment, including a body 312 defining a cavity 322 for attachment to a probe, probe cap, or the like. A platform 314 including a slotted needle guide channel 320 is also included. In particular, the platform 314 includes a notched arm 316 that is slidably disposed between two arcuate rails 318 of the body 312. So configured, the platform 314 is slidable along the rails 318 to enable the insertion angle of the guide channel 320 to be modified as desired by the user so as to enable a needle inserted therein to intercept an imaged subcutaneous target, such as a vessel [0060]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Allaway to include wherein the needle holder device is movable within the central opening between the first path angle orientation and the second path angle orientation, as taught by Oromo. Doing so would enable the insertion angle of the guide channel 320 to be modified as desired by the user so as to enable a needle inserted therein to intercept an imaged subcutaneous target, such as a vessel, as suggested by Oromo ([0060]).
Regarding claim 15, modified Allaway teaches the needle guidance device of claim 13, as discussed above. Allaway, however, does not teach wherein the needle holder device is movable within the central opening between a first path height position of the needle holder device with respect to the guide platform and a second path height position of the needle holder device with respect to the guide platform.
Orome, however, teaches wherein the needle holder device is movable within the central opening between a first path height position of the needle holder device with respect to the guide platform and a second path height position of the needle holder device with respect to the guide platform (FIGS. 11A and 11B show a needle guide assembly 310 according to another embodiment, including a body 312 defining a cavity 322 for attachment to a probe, probe cap, or the like. A platform 314 including a slotted needle guide channel 320 is also included. In particular, the platform 314 includes a notched arm 316 that is slidably disposed between two arcuate rails 318 of the body 312. So configured, the platform 314 is slidable along the rails 318 to enable the insertion angle of the guide channel 320 to be modified as desired by the user so as to enable a needle inserted therein to intercept an imaged subcutaneous target, such as a vessel [0060]; the needle can go across different heights/positions).
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Fig. 12A of Orome reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Allaway to include wherein the needle holder device is movable within the central opening between a first path height position of the needle holder device with respect to the guide platform and a second path height position of the needle holder device with respect to the guide platform. Doing so would enable the insertion angle of the guide channel to be modified as desired by the user so as to enable a needle inserted therein to intercept an imaged subcutaneous target, such as a vessel, as suggested by Orome ([0060]).
Regarding claim 16, Allaway teaches a needle guidance device, comprising:
a guide platform (lower mount 2704 [0203]; [fig. 27] reproduced below) configured to removably couple to an ultrasound probe (The lower mount 2704 includes a probe coupling or fastening mechanism 2706 to couple the lower mount 2704 with a transrectal probe [0203]; fastening mechanism is inherently releasable, example disclosed in [0246]), the ultrasound probe having a length extending along a longitudinal axis of the ultrasound probe (ultrasound probe inherently has a length/longitudinal axis that goes down the length of the device, ultrasound probe shown in fig. 1);
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Fig. 27 of Allaway reproduced above
a guide tower (upper mount 2702 [0203]; [fig. 27]) extending from the guide platform (the rail 2764 may engage with a platform 2766 of the upper mount coupling mechanism 2714 of the lower mount 2704 so as to align the upper and lower mounts 2702, 2704 upon coupling together [0212]; guide tower 2704 extends from guide platform 2704 as shown in fig. 27); and
… the needle holder device (vertically extending member 2760 includes five needle receiving ports 2768 [0216]; [fig. 28] reproduced above) defining a central aperture therethrough configured to receive a puncture device (Each of the openings 2770 of the needle receiving ports 2768 are generally vertically aligned with each other and each includes a trajectory axis 2776 defining a trajectory of the access needle 2712 when positioned within the opening 2770 [0214]; [fig. 32a] reproduced below; the needle receiving port that is aligned is the central aperture as claimed).
Allaway, however does not teach a needle holder device rotatably coupled to the guide tower, and the needle holder device rotatably movable about an axis perpendicular to the longitudinal axis with respect to the guide tower to move the puncture device from a first path angle orientation of a plurality of path angle orientations within a plane including the longitudinal axis to a second path angle orientation of the plurality of path angle orientations within the plane different from the first path angle orientation.
Orome is considered analogous to the instant application as “Needle Guide with Selectable Aspects” is disclosed (title).
Orome teaches:
a needle holder device ( needle guide assembly 860; [520]) rotatably coupled to the guide tower (the needle guide assembly itself is pivotally attached to an ultrasound probe 850 via an arm 870 pivotally attached to the probe [0082]; the arm 870 has a rotates around a fixed point)
the needle holder device rotatably movable about an axis perpendicular to the longitudinal axis (longitudinal axis and axis perpendicular to it is labeled below) with respect to the guide tower to move the puncture device from a first path angle orientation of a plurality of path angle orientations within a plane including the longitudinal axis to a second path angle orientation of the plurality of path angle orientations within the plane different from the first path angle orientation (This enables the needle 70 received by the guide channel 864 to be positioned in one of at least two positions: a first position wherein the needle 70 is disposed relatively far from the patient's skin, and a second position (caused by distal pivoting of the needle guide assembly arm 870) wherein the distal tip of the needle is positioned relatively close to the skin surface. The clinician can then distally advance the needle 70 as desired. [0082]; the needle can go across two path angles “position 1” and “position 2” shown below).
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Fig. 24 of Orome reproduced above with annotations
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Allaway to include a needle holder device rotatably coupled to the guide tower, and the needle holder device rotatably movable about an axis perpendicular to the longitudinal axis with respect to the guide tower to move the puncture device from a first path angle orientation of a plurality of path angle orientations within a plane including the longitudinal axis to a second path angle orientation of the plurality of path angle orientations within the plane different from the first path angle orientation, as taught by Orome. Doing so would facilitate proper placement of a needle into a patient so as to access a desired target at a particular subcutaneous depth, such as a vessel, for instance ([0040]).
Regarding claim 17, modified Allaway teaches the needle guidance device of claim 16, as discussed above. Allaway further teaches wherein the needle holder device is positionable at a plurality of path height positions, each path height position of the plurality of path height positions located at a corresponding distance from a surface of the guide platform (Each needle receiving port 2768 includes an opening 2770 extending from a distal end 2772 to a proximal end 2774 of the displacement member 2710. Each of the openings 2770 of the needle receiving ports 2768 are generally vertically aligned with each other and each includes a trajectory axis 2776 defining a trajectory of the access needle 2712 when positioned within the opening 2770 [0214]).
Regarding claim 18, modified Allaway teaches the needle guidance device of claim 16, as discussed above. Allaway, however, does not teach wherein the guide tower extends radially outwardly from the guide platform within the plane. Orome, however, teaches wherein the guide tower extends radially (750) outwardly from the guide platform (outside of 850) within the plane (radially outward direction notated below).
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Annotated fig. 24 reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Allaway, to include wherein the needle holder device is positionable at a plurality of path height positions, each path height position of the plurality of path height positions located at a corresponding distance from a surface of the guide platform, as taught by Orome. Doing so would facilitate proper placement of a needle into a patient so as to access a desired target at a particular subcutaneous depth, such as a vessel, for instance ([0040]).
Regarding claim 19, Allaway teaches a needle guidance device, comprising:
a guide platform (lower mount 2704 [0203]; [fig. 27] reproduced below) configured to removably couple to an ultrasound probe (The lower mount 2704 includes a probe coupling or fastening mechanism 2706 to couple the lower mount 2704 with a transrectal probe [0203]; fastening mechanism is inherently releasable, example disclosed in [0246]), the ultrasound probe having a length extending along a longitudinal axis of the ultrasound probe(ultrasound probe inherently has a length/longitudinal axis that goes down the length of the device, ultrasound probe shown in fig. 1);
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Fig. 27 of Allaway reproduced above
a guide tower (upper mount 2702 [0203]; [fig. 27]) extending from the guide platform (the rail 2764 may engage with a platform 2766 of the upper mount coupling mechanism 2714 of the lower mount 2704 so as to align the upper and lower mounts 2702, 2704 upon coupling together [0212]; guide tower 2704 extends from guide platform 2704 as shown in fig. 27),
a needle holder device ( vertically extending member 2760 includes five needle receiving ports 2768 [0216]; [fig. 28] reproduced above) movably positioned with the central opening to adjust at least one of a path angle orientation or a path height position of the needle holder device in a plane including the longitudinal axis, the needle holder device defining a central aperture extending therethrough from a proximal surface of the needle holder device to an opposite distal surface of the needle holder device and configured to receive a puncture device (Each of the openings 2770 of the needle receiving ports 2768 are generally vertically aligned with each other and each includes a trajectory axis 2776 defining a trajectory of the access needle 2712 when positioned within the opening 2770 [0214]; [fig. 32a] reproduced below; the needle receiving port that is aligned is the central aperture as claimed).
Allaway, however, does not teach: the guide tower defining a central opening; and a needle holder device movably positioned with the central opening to adjust at least one of a path angle orientation or a path height position of the needle holder device in a plane including the longitudinal axis, the needle holder device defining a central aperture extending therethrough from a proximal surface of the needle holder device to an opposite distal surface of the needle holder device and configured to receive a puncture device.
Orome is considered analogous to the instant application as “Needle Guide with Selectable Aspects” is disclosed (title).
Orome teaches:
the guide tower (22) defining a central opening (314); and
teach a needle holder device (310) movably positioned with the central opening to adjust at least one of a path angle orientation or a path height position of the needle holder device in a plane including the longitudinal axis, the needle holder device defining a central aperture extending therethrough from a proximal surface of the needle holder device to an opposite distal surface of the needle holder device and configured to receive a puncture device (FIGS. 11A and 11B show a needle guide assembly 310 according to another embodiment, including a body 312 defining a cavity 322 for attachment to a probe, probe cap, or the like. A platform 314 including a slotted needle guide channel 320 is also included. In particular, the platform 314 includes a notched arm 316 that is slidably disposed between two arcuate rails 318 of the body 312. So configured, the platform 314 is slidable along the rails 318 to enable the insertion angle of the guide channel 320 to be modified as desired by the user so as to enable a needle inserted therein to intercept an imaged subcutaneous target, such as a vessel [0060]).
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Fig. 12A of Orome reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Allaway to include the guide tower defining a central opening; and a needle holder device movably positioned with the central opening to adjust at least one of a path angle orientation or a path height position of the needle holder device in a plane including the longitudinal axis, the needle holder device defining a central aperture extending therethrough from a proximal surface of the needle holder device to an opposite distal surface of the needle holder device and configured to receive a puncture device as taught by Orome. Doing so would enable the insertion angle of the guide channel to be modified as desired by the user so as to enable a needle inserted therein to intercept an imaged subcutaneous target, such as a vessel, as suggested by Orome ([0060]).
Regarding claim 20, modified Allaway teaches the needle guidance device of claim 19, as discussed above. Allaway, however, does not teach wherein the needle holder device is rotatable about an axis perpendicular to the longitudinal axis to rotate the puncture device from a first path angle orientation of a plurality of path angle orientations within the plane to a second path angle orientation of the plurality of path angle orientations within the plane different from the first path angle orientation.
Orome, however, teaches wherein the needle holder device is rotatable about an axis perpendicular to the longitudinal axis (longitudinal axis and axis perpendicular to it is labeled below) to rotate the puncture device from a first path angle orientation of a plurality of path angle orientations within the plane to a second path angle orientation of the plurality of path angle orientations within the plane different from the first path angle orientation (This enables the needle 70 received by the guide channel 864 to be positioned in one of at least two positions: a first position wherein the needle 70 is disposed relatively far from the patient's skin, and a second position (caused by distal pivoting of the needle guide assembly arm 870) wherein the distal tip of the needle is positioned relatively close to the skin surface. The clinician can then distally advance the needle 70 as desired. [0082]; the needle can go across two path angles “position 1” and “position 2” shown below).
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Fig. 24 of Orome reproduced above with annotations
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Allaway to include wherein the needle holder device is rotatable about an axis perpendicular to the longitudinal axis to rotate the puncture device from a first path angle orientation of a plurality of path angle orientations within the plane to a second path angle orientation of the plurality of path angle orientations within the plane different from the first path angle orientation, as taught by Orome. Doing so would facilitate proper placement of a needle into a patient so as to access a desired target at a particular subcutaneous depth, such as a vessel, for instance ([0040]).
Claims 3, 7, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Allaway (US 20160022309 A1) in view of Orome (US 20120330159 A1) and Schlitt et al. (US 20100041990 A1, hereinafter “Schlitt”).
Regarding claim 3, modified Allaway teaches the needle guidance device of claim 1, as discussed above. Allaway, however, does not teach an adjustment knob operatively coupled to the needle holder device, the adjustment knob configured to secure the needle holder device at the first path angle orientation.
Schlitt is considered analogous to the instant application as “Needle Guides for Catheter Delivery” is disclosed (title). Schlitt te