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 Amendment
This office action is in response to the remarks filed on 08/22/2025.
The amendment filed 08/22/2025 has been entered. Claims 1-20 remain pending in the application, claims 21-35 have been canceled.
Election/Restrictions
Applicant’s election without traverse of claims 1-20 in the reply filed on 08/22/2025 is acknowledged.
Claims 21-35 have been cancelled.
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 1-3, 13-15, and 19-20 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 needle guidance device having a longitudinal axis (longitudinal axis labeled in fig.1 below), comprising:
a guide base (2704) configured to releasably attach 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 releasable, example disclosed in [0246]), the guide base including a platform (platform 2766 [0212]; fig. 28);
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Fig. 27 of Allaway reproduced above with annotations
a guide tower (upper mount 2702 [0203]; [fig. 27]) fixedly coupled to the guide base (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]), the guide tower extending distally from a distal end of the guide base along the longitudinal axis (guide tower 2702 extends along the longitudinal axis, annotated above) and extending perpendicularly with respect to the longitudinal axis from the platform (guide tower extends upwards/perpendicularly with respect to the longitudinal axis annotated above), the guide tower comprising a plurality of attachment positions (vertically extending member 2760 includes five needle receiving ports 2768 [0216]; [fig. 28] reproduced above); and
Allaway, however, does not teach an introducer holder removably and pivotably coupled to the guide tower at a first attachment position of the plurality of attachment positions.
Orome is considered analogous to the instant application as “Needle Guide with Selectable Aspects” is disclosed (title).
Orome teaches:
an introducer holder removably (needle guide assembly 860; [520]) and pivotably coupled to the guide tower at a first attachment position ((the needle guide assembly itself is pivotally attached to an ultrasound probe 850 via an arm 870 pivotally attached to the probe [0082]) of the plurality of attachment positions ((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
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 an introducer holder removably and pivotably coupled to the guide tower at a first attachment position of the plurality of attachment position, 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 guide base comprises:
a mount portion (upper mount coupling mechanism 2714 to couple the lower mount 2704 with the upper mount 2702 [0203]; [fig. 27] reproduced below) fixedly coupled to the guide tower (upper mount 2702 [0203] [fig. 27] reproduced below); and
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Fig. 27 of Allaway reproduced above
a strap portion coupled to the mount portion (The lower mount 3704 is adapted to secure the guide 3700 to a transrectal probe and [0239]; [fig. 37C] reproduced below);
the strap portion configured to releasably attach the needle guidance device to the 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]; The lower mount 4208 may include a cinch strap 4202...cinch strap 4202 may be fitted around the transrectal probe 4222 [0253]; a cinch strap and fastening mechanism are inherently releasable; [fig 37M] reproduced below).
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Fig. 37C and 37M of Allaway reproduced above
Regarding claim 3, modified Allaway teaches needle guidance device of claim 1, as discussed above. Allaway further teaches wherein the introducer holder is positionable at each attachment position of the plurality of attachment positions to prevent movement of the introducer holder 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 13, modified Allaway teaches the needle guidance device of claim 1, as discussed above. Allaway further teaches further comprising an introducer needle (2412), wherein the introducer holder defines a central passage configured to receive the introducer needle and maintain the introducer needle within a plane including the longitudinal axis (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 is maintained within the plane of the longitudinal axis as it is fixed in place).
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Fig. 27 of Allaway reproduced above with annotations
Regarding claim 14, modified Allaway teaches the needle guidance device of claim 13, as discussed above. Allaway further teaches wherein the introducer needle comprises a distal tip (2836), an opposite proximal end (2838), and a stop at the proximal end (2846 and 2848) configured to limit movement of the introducer needle within the central passage in a distal direction with respect to the guide tower (The proximal end 2838 of the needle 2712 includes hub 2846 with ridges 2848 extending longitudinally around a circumference of the hub 2846. The ridges 2848 may engage with corresponding and negatively shaped features on the proximal side 2800 of the needle receiving ports 2768; the hub stops the needle from moving).
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Fig. 34 of Allaway reproduced above
Regarding claim 15, modified Allaway teaches the needle guidance device of claim 1, as discussed above. Allaway further teaches wherein the introducer holder 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 platform (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).
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 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 with annotations
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 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
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),
and the needle holder device rotatably movable about a rotational 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 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, 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 20, modified Allaway teaches the needle guidance device of claim 19, 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]).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Allaway (US 20160022309 A1) in view of Orome (US 20120330159 A1) and Howlett et al. (US 20130150714 A1, of record, hereinafter "Howlett").
Regarding claim 4, modified Allaway teaches needle guidance device of claim 1, as discussed above. Allaway further teaches wherein the introducer holder (vertically extending member 2760 includes five needle receiving ports 2768 [0216]; [fig. 28] reproduced above) comprises:
a body portion having a distal end, an opposite proximal end, and a central passage extending along a centerline of the body portion between the distal end and the proximal end (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);
and a pair of opposing engagement shoulders (tab members 2780 in figs 32A-32C; [0217]; [fig. 32a] reproduced above), each engagement shoulder of the pair of opposing engagement shoulders extending radially outwardly from the centerline of the body portion at the distal end of the body portion (the shoulders are radially outward outside of the centerline of the body portion, radial outward direction labelled below) ,
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Fig. 32A reproduced above with annotations
Allaway, however does not teach wherein the guide tower comprises a plurality of paired arcuate-shaped depressions at each attachment position of the plurality of attachment positions, and a first pair of arcuate- shaped depressions of the plurality of paired arcuate-shaped depressions at the first attachment position is positioned at a first distance from a surface of the platform, and each engagement shoulder of the pair of opposing engagement shoulders is removably and pivotably positionable within a corresponding arcuate-shaped depression of the first pair of arcuate- shaped depressions.
Howlett is considered to be analogous to the claimed invention as an ultrasound imaging system and needle guidance system is disclosed ([0005]). Howlett teaches:
Howlett teaches wherein the guide tower comprises a plurality of paired arcuate-shaped depressions at each attachment position of the plurality of attachment positions (slots 80 on needle guide holder in Fig. 1; [0049]), and a first pair of arcuate- shaped depressions of the plurality of paired arcuate-shaped depressions at the first attachment position is positioned at a first distance from a surface of the platform (Needle guide holder 30 seen by example in FIG. 1 is preferably integrally molded with transducer basket 20. Holder 20 comprises a plurality of slots (generally numbered 80) disposed at varying predetermined angles to achieve proper angles and depths [0049]; the slots, which are in a bent formation, are arcuate-shaped depressions that have different attachment positions at different positions), and each engagement shoulder of the pair of opposing engagement shoulders is removably and pivotably positionable within a corresponding arcuate-shaped depression of the first pair of arcuate- shaped depressions (wings which are then fitted into the needle guide holder of the basket… needle guide holder may comprise slots for positioning an associated guide and anchor assembly channel and needle/cannula into a desired position and angle for advancing the needle/cannula through the skin and into a target vessel [0008]; two wings 92/shoulder as seen in [fig. 2], reproduced below; further, as the needle is attached to wings that are fitted into the needle guide holder, the depressions are capable of receiving the engagement shoulders/wings pivotably).
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Fig. 1 and Fig. 3 of Howlett 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 invention of Allaway to include wherein the guide tower comprises a plurality of paired arcuate-shaped depressions at each attachment position of the plurality of attachment positions, and a first pair of arcuate- shaped depressions of the plurality of paired arcuate-shaped depressions at the first attachment position is positioned at a first distance from a surface of the platform, and each engagement shoulder of the pair of opposing engagement shoulders is removably and pivotably positionable within a corresponding arcuate-shaped depression of the first pair of arcuate- shaped depressions, as taught by Howlett, in order to prevent inadvertent movement and/or removal of the needle, as suggested by Howlett ([0004]).
Regarding claim 5, modified Allaway teaches needle guidance device of claim 4, as discussed above. Allaway, however does not teach with the introducer holder rotatably coupled to the guide tower at one attachment position of the plurality of attachment positions, the introducer holder is pivotably movable with respect to the guide tower about an axis perpendicular to the longitudinal axis to move an introducer needle positioned within the central passage of the introducer holder 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, however, teaches
wherein, with the introducer holder rotatably coupled to the guide tower at one attachment position of the plurality of attachment positions (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 introducer holder is pivotably movable with respect to the guide tower (850) about an axis perpendicular to the longitudinal axis (longitudinal axis and axis perpendicular to it is labeled below) to move an introducer needle positioned within the central passage of the introducer holder 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 the introducer holder rotatably coupled to the guide tower at one attachment position of the plurality of attachment positions, the introducer holder is pivotably movable with respect to the guide tower about an axis perpendicular to the longitudinal axis to move an introducer needle positioned within the central passage of the introducer holder 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 6, modified Allaway teaches the needle guidance device of claim 5, as discussed above. Allaway, however, does not teach wherein the introducer holder is lockable at each path angle orientation of the plurality of path angle orientations to prevent movement of the introducer holder in a distal direction and an opposite proximal direction with respect to the guide tower.
Orome, however, teaches wherein the introducer holder is lockable at each path angle orientation of the plurality of path angle orientations to prevent movement of the introducer holder in a distal direction and an opposite proximal direction with respect to the guide tower (The pivoting arm 870 can include one or more locking features for locking the needle guide in the first and/or second positions. Moreover, additional positions can be included [0082]).
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 introducer holder is lockable at each path angle orientation of the plurality of path angle orientations to prevent movement of the introducer holder in a distal direction and an opposite proximal direction with respect to the guide tower, 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]).
Claim 7 as being unpatentable over Allaway (US 20160022309 A1) in view of Orome (US 20120330159 A1), Howlett et al. (US 20130150714 A1, of record, hereinafter "Howlett"), and Schlitt et al. (US 20100041990 A1, hereinafter “Schlitt”).
Regarding claim 7, modified Allaway teaches the needle guidance device of claim 5, as discussed above. Allaway, however does not teach a locking knob operatively coupled to the introducer holder, the locking knob configured to secure the introducer holder in one of the first path angle orientation and the second path angle orientation.
Schlitt is considered analogous to the instant application as “Needle Guides for Catheter Delivery” is disclosed (title).
Schlitt teaches teach a locking knob (226) operatively coupled to the introducer holder (224), the locking knob configured to secure the introducer holder in one of the first path angle orientation and the second path angle orientation (needle lock takes the form of a set screw 226 for locking a needle 228 in the needle guide 224…. Thus, with one hand the practitioner controls the position of the probe 100 and the needle guide 224 relative to the patient. When the needle 228 is positioned in the area of interest in the patient, the practitioner locks the needle 228 in place by operating the set screw 226 [0050]).
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Figs. 7A and 7B of Schlitt 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 a locking knob operatively coupled to the introducer holder, the locking knob configured to secure the introducer holder in one of the first path angle orientation and the second path angle orientation, as taught by Schlitt. Doing so would allow for many positioning possibilities, as suggested by Schlitt ([0050]).
Claims 8-11 are rejected as being unpatentable over Allaway (US 20160022309 A1) in view of Orome (US 20120330159 A1), Howlett et al. (US 20130150714 A1, of record, hereinafter "Howlett"), and Pajunk et al. (DE 102010008491 B4, hereinafter "Pajunk", previously attached WIPO translation is used for citations below) and Chisholm et al (US 20120253100 A1, hereinafter “Chisholm”).
Regarding claim 8, modified Allaway teaches the needle guidance device of claim 4, as discussed above. Allaway, however, does not teach a spring element positioned adjacent a first arcuate-shaped depression of the first pair of arcuate- shaped depressions, the spring element comprising a resilient element configured to removably capture the introducer holder within the adjacent first arcuate-shaped depression.
Pajunk discloses “Device for guiding a medical cannula on an ultrasound head” (title). Pajunk teaches a spring element positioned adjacent a first … depression of the first pair of …. Depressions (springs 42 are on adjacent sides; [fig.1] reproduced below), the spring element comprising a resilient element configured to removably capture the introducer holder within the adjacent first … depression (The detent springs 42 engage with their projections 46 resiliently into the recesses 28 of the angle detents 26 [0037]; fig, 1 shows all of the elements, springs 42 lock the cannula/needle in shape within the holder 16, angle detents 26 are within the introducer holder).
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Fig. 1 of Pajunk reproduce 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 a spring element positioned adjacent a first depression of the first pair of depressions, the spring element comprising a resilient element configured to removably capture the introducer holder within the adjacent first arcuate-shaped depression, as taught by Pajunk, in order to achieve simple handling and alignment of the cannula/needle, as suggested by Pajunk ([0006]).
The combined invention, still however, does not teach an first arcuate-shaped depression.
Chisholm is considered analogous to the instant application, as needle-based medical device is disclosed (abstract). Chisholm teaches an arcuately shaped depression (In FIG. 3E, notch 16 e is defined by either an arcuate or U-shaped notch edgewall. [0034]) (Referring now to FIGS. 3A-G, the present invention contemplates that notch 16 of brace 10 may take different forms and be located at different positions than shown in FIG. 1. In each case, the notch is defined to include a dimension larger than the cross-sectional width of said needle body so as to receive the needle body therein [0033]).
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 change the shape of the depression to an arcuate shape, as taught by Chisholm, in order to receive the needle body therein such that a tilting of the brace body with respect to the needle body will provide the desired grip to steady the needle body against bowing, as suggested by Chisholm ([0033]).
Regarding claim 9, modified Allaway teaches the needle guidance device of claim 4, as discussed above. Allaway, however, does not teach wherein the guide tower defines an opening, the needle guidance device further comprising:
a guide slide clamp movably positioned within a slot, the slot extending transversely through at least a portion of the guide tower and in communication with the opening, the guide slide clamp comprising a body portion and a plurality of path retaining elements axially aligned with a corresponding pair of arcuate-shaped depressions of the plurality of paired arcuate-shaped depressions to facilitate retaining the introducer holder at a corresponding parallel path position through the guide tower.
Pajunk is considered analogous to the instant application as “Device for guiding a medical cannula on an ultrasound head” is disclosed (title). Pajunk teaches guide tower (16) defines an opening (opening formed in between 26), the needle guidance device further comprising:
a guide slide clamp movably positioned within a slot (The guide sleeve preferably has a conical tip designed as a collet, which engages in an inner cone of the bore. lf the guide sleeve is rotated back, the collet chuck is released and the cannula received in the guide sleeve can be displaced axially. By rotating the guide sleeve, the collet clamps the cannula in its respective axial position [0012]), the slot extending transversely through at least a portion of the guide tower and in communication with the opening (slot is formed within guide tower/holder 16, within opening in-between as shown in fig. 1), the guide slide clamp comprising a body portion and a plurality of path retaining elements axially aligned with a corresponding pair of … depressions of the plurality of paired …depressions (depression/ detent 26 hold the needle in place; fig. 1) to facilitate retaining the introducer holder at a corresponding parallel path position through the guide tower (If the guide sleeve 36 is screwed into the bore 48 by means of its external thread 60, the conical collet 64 comes into axial engagement with the inner cone 52 of the bore 48 of the sector element 34, so that the collet chuck 64 is radially compressed and clamps a cannula 14 located in the inner bore 54 and fixes it in its axial position [0038]; parallel path formed as shown in fig. 1).
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Fig. 1 of Pajunk reproduce 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 a guide slide clamp movably positioned within a slot, the slot extending transversely through at least a portion of the guide tower and in communication with the opening, the guide slide clamp comprising a body portion and a plurality of path retaining elements axially aligned with a corresponding pair of depressions of the plurality of paired depressions to facilitate retaining the introducer holder at a corresponding parallel path position through the guide tower, as taught by Pajunk, in order to achieve simple handling and alignment of the cannula/needle, as suggested by Pajunk ([0006]).
The combined invention, still however, does not teach arcuate-shaped depressions.
Chisholm is considered analogous to the instant application, as needle-based medical device is disclosed (abstract). Chisholm teaches an arcuately shaped depression (In FIG. 3E, notch 16 e is defined by either an arcuate or U-shaped notch edgewall. [0034]) (Referring now to FIGS. 3A-G, the present invention contemplates that notch 16 of brace 10 may take different forms and be located at different positions than shown in FIG. 1. In each case, the notch is defined to include a dimension larger than the cross-sectional width of said needle body so as to receive the needle body therein [0033]).
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 change the shape of the depression to an arcuate shape, as taught by Chisholm, in order to receive the needle body therein such that a tilting of the brace body with respect to the needle body will provide the desired grip to steady the needle body against bowing, as suggested by Chisholm ([0033]).
Regarding claim 10, modified Allaway teaches the needle guidance device of claim 9, as discussed above. Allaway, however, does not teach wherein the plurality of path retaining elements comprise a plurality of detents formed within the body portion of the guide slide clamp, and each detent of the plurality of detents is axially aligned with a first arcuate- shaped depression of the corresponding pair of arcuate-shaped depressions.
Pajunk, however, teaches wherein the plurality of path retaining elements comprise a plurality of detents (26) formed within the body portion of the guide slide clamp, and each detent of the plurality of detents is axially aligned with a first … depression of the corresponding pair of … depressions (The guide sleeve preferably has a conical tip designed as a collet, which engages in an inner cone of the bore. lf the guide sleeve is rotated back, the collet chuck is released and the cannula received in the guide sleeve can be displaced axially. By rotating the guide sleeve, the collet clamps the cannula in its respective axial position. The cannula can thus be positioned axially and fixed in any desired axial position. [0012]) The detent springs 42 engage with their projections 46 resiliently into the recesses 28 of the angle detents 26 [0037]; fig, 1 shows all of the elements, springs 42 lock the cannula/needle in place within the holder 1).
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 plurality of path retaining elements comprise a plurality of detents formed within the body portion of the guide slide clamp, and each detent of the plurality of detents is axially aligned with a first depression of the corresponding pair of depressions, as taught by Pajunk, in order to achieve simple handling and alignment of the cannula/needle, as suggested by Pajunk ([0006]).
The combined invention, still however, does not teach arcuate-shaped depressions.
Chisholm is considered analogous to the instant application, as needle-based medical device is disclosed (abstract). Chisholm teaches an arcuately shaped depression (In FIG. 3E, notch 16 e is defined by either an arcuate or U-shaped notch edgewall. [0034]) (Referring now to FIGS. 3A-G, the present invention contemplates that notch 16 of brace 10 may take different forms and be located at different positions than shown in FIG. 1. In each case, the notch is defined to include a dimension larger than the cross-sectional width of said needle body so as to receive the needle body therein [0033]).
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 change the shape of the depression to an arcuate shape, as taught by Chisholm, in order to receive the needle body therein such that a tilting of the brace body with respect to the needle body will provide the desired grip to steady the needle body against bowing, as suggested by Chisholm ([0033]).
Regarding claim 11, modified Allaway teaches the needle guidance device of claim 10, as discussed above. Allaway, however does not teach wherein the body portion of the guide slide clamp further comprises a parallel path alignment feature, and wherein at least one detent of the plurality of detents is configured to selectively engage the parallel path alignment feature to retain the introducer holder in a parallel path orientation.
Pajunk, however, teaches wherein the body portion of the guide slide clamp further comprises a parallel path alignment feature (20), and wherein at least one detent of the plurality of detents is configured to selectively engage the parallel path alignment feature to retain the introducer holder in a parallel path orientation (The guide sleeve preferably has a conical tip designed as a collet, which engages in an inner cone of the bore. lf the guide sleeve is rotated back, the collet chuck is released and the cannula received in the guide sleeve can be displaced axially. By rotating the guide sleeve, the collet clamps the cannula in its respective axial position. The cannula can thus be positioned axially and fixed in any desired axial position. [0012]) The detent springs 42 engage with their projections 46 resiliently into the recesses 28 of the angle detents 26 [0037]; fig, 1 shows all of the elements, springs 42 lock the cannula/needle in place within the holder 1; the parallel alignment feature 20 is parallel as shown in figs. 1 and 3, fig. 3 reproduced below).
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Fig. 3 of Pajunk 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 body portion of the guide slide clamp further comprises a parallel path alignment feature, and wherein at least one detent of the plurality of detents is configured to selectively engage the parallel path alignment feature to retain the introducer holder in a parallel path orientation, as taught by Pajunk, in order to achieve simple handling and alignment of the cannula/needle, as suggested by Pajunk ([0006]).
Claims 12 is rejected as being unpatentable over Allaway (US 20160022309 A1) in view of Orome (US 20120330159 A1), Howlett et al. (US 20130150714 A1, of record, hereinafter "Howlett"), and Pajunk et al. (DE 102010008491 B4, of record, hereinafter "Pajunk", WIPO translation is used for citations below) and Chisholm et al (US 20120253100 A1, hereinafter “Chisholm”), and Onik et al. (US 5494039 A, hereinafter "Onik")
Regarding claim 12, modified Allaway teaches the needle guidance device of claim 11, as discussed above. Allaway, however, does not teach wherein the guide tower comprises a threaded aperture aligned with the slot for receiving a threaded screw, wherein the threaded screw projects from a locking knob and engages the guide slide clamp to urge the at least one detent into engagement with the introducer holder at a desired parallel path orientation via the parallel path alignment feature.
Onik discloses “Biopsy Needle Insertion Guide And Method Of Use In Prostate Cryosurgery” (title). Onik teaches wherein the guide tower (a slide block 16 which provides anterior-posterior positioning adjustment for a biopsy needle relative to ultrasound probe; Col. 4 lines 36-70; slide block is the guide tower, [fig. 1] reproduced below) comprises a threaded aperture aligned with the slot for receiving a threaded screw (position locking thumb screw 17 which, as is seen in FIGS. 1 and 2, extends through slot 5 to engage slide block 16.; Col. 4 lines 47-48; screws are known in the art to be threaded, and it engages with slot 5, [figs 1 and 2] reproduced below), wherein the threaded screw projects from a locking knob (As seen in FIGS. 8 and 9, slide block 16 is designed to cooperate with slot 5 and slot track 6 in adjustment guide 4. To this end, slide block 16 is provided with a track following lug 19 on one face which fits into slot track 6 to guide slide block 16 along adjustment guide; Col 4 lines 40-44; lug 19/locking knob as seen in [figs. 8 and 9], reproduced below, correspond to locking thumb screw 17/threaded bolt seen in Figs 1 and 2 which depict the opposite facing side) and engages the guide slide clamp to urge the at least one detent into engagement with the introducer holder at a desired parallel path orientation via the parallel path alignment feature (Thumb screw 17 is loosened to permit slide block 16 to move along adjustment guide 4 and is tightened against the outer face of adjustment guide 4 to fix slide block 16 in a desired position; col 4 lines 49-53; parallel movement occurs as there is a back/forth movement).
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Figs 1 and 2 of Onik 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 comprises a threaded aperture aligned with the slot for receiving a threaded screw, wherein the threaded screw projects from a locking knob and engages the guide slide clamp to urge the at least one detent into engagement with the introducer holder at a desired parallel path orientation via the parallel path alignment feature, as taught by Onik, in order to facilitate stabilization of the needle.
Claims 16-18 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 16, modified Allaway teaches the needle guidance device of claim 15, as discussed above. Allaway, however, does not teach comprising a locking knob (226) operatively coupled to the introducer holder (224), the locking knob configured to secure the introducer holder at a first path height position of the plurality of path height positions (needle lock takes the form of a set screw 226 for locking a needle 228 in the needle guide 224…. Thus, with one hand the practitioner controls the position of the probe 100 and the needle guide 224 relative to the patient. When the needle 228 is positioned in the area of interest in the patient, the practitioner locks the needle 228 in place by operating the set screw 226 [0050]; needle can be set to various heights as seen below).
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Figs 7B of Schlitt 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 a locking knob operatively coupled to the introducer holder, the locking knob configured to secure the introducer holder at a first path height position of the plurality of path height positions, as taught by Schlitt. Doing so would allow for many positioning possibilities, as suggested by Schlitt ([0050]).
Regarding claim 17, modified Allaway teaches the needle guidance device of claim 16, as discussed above. Allaway, however, does not teach wherein the guide tower defines an opening and the introducer holder is movably positionable within the opening to adjust at least one of a path angle orientation or a path height position of the introducer holder.
Orome, however, teaches wherein the guide tower (22) defines an opening (opening between rails 318), and the introducer holder (314) is movably positionable within the opening to adjust at least one of a path angle orientation or a path height position of the introducer holder (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 an opening and the introducer holder is movably positionable within the opening to adjust at least one of a path angle orientation or a path height position of the introducer holder, 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 18, modified Allaway teaches the needle guidance device of claim 17, a discussed above. Allaway, however, does not teach a locking knob operatively coupled to the introducer holder, the locking knob configured to secure the introducer holder at the at least one of the path angle orientation or the path height position.
Schlitt is considered analogous to the instant application as “Needle Guides for Catheter Delivery” is disclosed (title). Schlitt teaches:
teach a locking knob (226) operatively coupled to the introducer holder (224), the locking knob configured to secure the introducer holder at the at least one of the path angle orientation or the path height position (needle lock takes the form of a set screw 226 for locking a needle 228 in the needle guide 224…. Thus, with one hand the practitioner controls the position of the probe 100 and the needle guide 224 relative to the patient. When the needle 228 is positioned in the area of interest in the patient, the practitioner locks the needle 228 in place by operating the set screw 226 [0050]).
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 locking knob operatively coupled to the introducer holder, the locking knob configured to secure the introducer holder at the at least one of the path angle orientation or the path height position, as taught by Schlitt. Doing so would allow for many positioning possibilities, as suggested by Schlitt ([0050]).
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 mu