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 21-40 in the reply filed on 08/22/2025 is acknowledged.
Claims 1-20 have been previously 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 21, 26-31, 26-37, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Allaway (US 20160022309 A1, of record) in view of Barzell et al. (US 20040143150 A1, hereinafter “Barzell”) and Howlett et al. (US 20130150714 A1, of record, hereinafter "Howlett").
Regarding claim 21, Allaway teaches a needle guidance device, comprising
a first portion (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 ultrasound probe defining a longitudinal axis (longitudinal axis labeled in fig.1 below),;
a second portion (upper mount 2702 [0203]; [fig. 27]) coupled to the first portion (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]) and extending from the first portion (first portion 2702 extends along the longitudinal axis, annotated above),
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Fig. 27 of Allaway reproduced above with annotations
Allaway, however, does not teach: the second portion comprising a frame having a first member and a second member forming at least a portion of a guidance slot, the frame including a plurality of pairs of aligned receiving channels, each pair of aligned receiving channels of the plurality of pairs of aligned receiving channels including a first receiving channel on the first member and a second receiving channel on the second member aligned with the first receiving channel at a respective distance from the longitudinal axis; and
a needle holder device comprising a body defining a central aperture and a pair of engagement shoulders extending outwardly from a central axis, wherein the pair of engagement shoulders are movably positionable within each pair of aligned receiving channels to retain the needle holder device with the central aperture aligned with the guidance slot at the respective distance from the longitudinal axis.
Barzell is considered analogous to the instant application as “Template grid system” is disclosed (title).
Barzell teaches:
the second portion comprising a frame (100 [0044]; fig. 11; template grid 100 has proximal and distal members 102, 104 that are removably coupled [0044]) having a first member (102 [0044]; fig. 11) and a second member (104 [0044]; fig. 11) forming at least a portion of a guidance slot (slot 24 that has a length substantially larger than its width [0029]), the frame including a plurality of pairs of aligned receiving channels (Passages 12 [0044]; when proximal and distal members 102, 104 are coupled, parallel placement of needles is achieved [0044]), each pair of aligned receiving channels of the plurality of pairs of aligned receiving channels including a first receiving channel on the first member and a second receiving channel on the second member aligned with the first receiving channel at a respective distance from the longitudinal axis (Passages 12 [0044]; when proximal and distal members 102, 104 are coupled, parallel placement of needles is achieved [0044]; [0034] further discloses that the channels 12 are parallel; [0005] discloses that the grid is in a fixed position with respect to an ultrasound probe).
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Fig.11 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 the second portion comprising a frame having a first member and a second member forming at least a portion of a guidance slot, the frame including a plurality of pairs of aligned receiving channels, each pair of aligned receiving channels of the plurality of pairs of aligned receiving channels including a first receiving channel on the first member and a second receiving channel on the second member aligned with the first receiving channel at a respective distance from the longitudinal axis, as taught by Barzell, in order to achieve the template grid can be used in different configuration to suit the user's needs, as suggested by Barzell ([0014]).
The combined invention still does not teach a needle holder device comprising a body defining a central aperture and a pair of engagement shoulders extending outwardly from a central axis, wherein the pair of engagement shoulders are movably positionable within each pair of aligned receiving channels to retain the needle holder device with the central aperture aligned with the guidance slot at the respective distance from the longitudinal axis.
Howlett is considered to be analogous to the claimed invention as an ultrasound imaging system and needle guidance system is disclosed ([0005]).
Howlett teaches:
a needle holder device comprising a body (assembly 40 [0067]; fig. 4) defining a central aperture (slots 80 have a spacing in between which is the central aperture as claimed) and a pair of engagement shoulders extending outwardly from a central axis (guide 40′ comprises a pair of wings, generally numbered 92′ [0069]; extends outwardly from dashed line 112 as shown in fig. 4), wherein the pair of engagement shoulders are movably positionable within each pair of aligned receiving channels (guide slots 80 [0051]) to retain the needle holder device with the central aperture aligned with the guidance slot at the respective distance from the longitudinal axis ([0054] disclose positioning shoulders 92; molded transducer basket and needle guide holder which has a plurality of guide slots for achieving various angles and depths of penetration for accessing a vessel [0023]; the needle stays aligned with the respect to the center/longitudinal axis of the probe, the attachment with the probe 60 shown in fig. 8).
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Fig. 3 and Fig. 4 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 combined invention of Allaway to include a needle holder device comprising a body defining a central aperture and a pair of engagement shoulders extending outwardly from a central axis, wherein the pair of engagement shoulders are movably positionable within each pair of aligned receiving channels to retain the needle holder device with the central aperture aligned with the guidance slot at the respective distance from the longitudinal axis, as taught by Howlett, in order to prevent inadvertent movement and/or removal of the needle, as suggested by Howlett ([0004]).
Regarding claim 26, modified Allaway teaches the needle guidance device of claim 21, as discussed above. Allaway, however, does not teach wherein the body is configured to receive a puncture device within the central aperture, the central aperture extending between a first end forming the pair of engagement shoulders and a second end opposite the first end forming a handle, wherein the puncture device is movable within the central aperture in a distal direction and an opposite proximal direction with respect to the second portion.
Howlett, however, teaches wherein the body is configured to receive a puncture device within the central aperture (slots 80 have a spacing in between which is the central aperture as claimed), the central aperture extending between a first end forming the pair of engagement shoulders (guide 40′ comprises a pair of wings, generally numbered 92′ [0069]; on opposing sides of dashed line 112 )and a second end opposite the first end forming a handle (([0054] disclose positioning shoulders 92; molded transducer basket and needle guide holder which has a plurality of guide slots for achieving various angles and depths of penetration for accessing a vessel [0023]; wings/shoulders form a “handle” that are on opposite ends of the device).
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 is configured to receive a puncture device within the central aperture, the central aperture extending between a first end forming the pair of engagement shoulders and a second end opposite the first end forming a handle, as taught by Howlett, in order to prevent inadvertent movement and/or removal of the needle, as suggested by Howlett ([0004]).
The combined invention still does not teach wherein the puncture device is movable within the central aperture in a distal direction and an opposite proximal direction with respect to the second portion.
Barzell, however, teaches wherein the puncture device is movable within the central (24) aperture in a distal direction and an opposite proximal direction with respect to the second portion (Slot 24 extends from front 14 through back 16. As shown, slot 24 is centrally located on template grid 10 and runs vertically [0029]; The elongated slot allows a needle to be placed in Denonvilliers space at a desired angle [0009]; slot allows needle to be placed at various angles/heights that are different from each other, as well as inside and outside of the second portion 100 ,i.e. a distal direction and an opposite proximal direction with respect to the second portion).
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 puncture device is movable within the central aperture in a distal direction and an opposite proximal direction with respect to the second portion, as taught by Barzell, in order to achieve the template grid can be used in different configuration to suit the user's needs, as suggested by Barzell ([0014]).
Regarding claim 27, modified Allaway teaches needle guidance device of claim 21, as discussed above. Allaway further teaches wherein the needle holder device is positionable at a plurality of path height positions (vertically extending member 2760 includes five needle receiving ports 2768 [0216]); each path height position of the plurality of path height positions located at a corresponding distance from a platform of the first portion (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]; each are located at different distances with respect to the platform 2710; platform 2710 [0204]; fig. 27 ).
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Fig. 27 of Allaway reproduced above
Regarding claim 28, modified Allaway teaches the needle guidance device of claim 21, 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 ultrasound probe different than the first path height position (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]; each are located at different distances with respect to the platform 2710, ultrasound probe is within 2706; platform 2710 [0204]; fig. 27).
Regarding claim 29, modified Allaway teaches the needle guidance device of claim 21, as discussed above. Allaway, however, is silent regarding wherein the second portion defines a central opening, the needle holder device movable within the central opening to adjust at least one of a path angle orientation of the needle holder device within a plane including the longitudinal axis or a path height position of the needle holder device at a distance with respect to the ultrasound probe within the plane.
Barzell, however, teaches wherein the second portion (100) defines a central opening (Slot 24 extends from front 14 through back 16. As shown, slot 24 is centrally located on template grid 10 and runs vertically [0029]), the needle holder device movable within the central opening to adjust at least one of a path angle orientation of the needle holder device within a plane including the longitudinal axis or a path height position of the needle holder device at a distance with respect to the ultrasound probe within the plane (The elongated slot allows a needle to be placed in Denonvilliers space at a desired angle [0009]; slot allows needle to be placed at various angles/heights)
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Fig. 11 of Barzell 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 second portion defines a central opening, the needle holder device movable within the central opening to adjust at least one of a path angle orientation of the needle holder device within a plane including the longitudinal axis or a path height position of the needle holder device at a distance with respect to the ultrasound probe within the plane, as taught by Barzell, in order to achieve the template grid can be used in different configuration to suit the user's needs, as suggested by Barzell ([0014]).
Regarding claim 30, modified Allaway teaches the needle guidance device of claim 29, as discussed above. Allaway, however, does not teach wherein the needle holder device is movable within the central opening between a first path angle orientation and a second path angle orientation different than the first path angle orientation.
Barzell, however, teaches wherein the needle holder device is movable within the central opening between a first path angle orientation and a second path angle orientation different than the first path angle orientation (Slot 24 extends from front 14 through back 16. As shown, slot 24 is centrally located on template grid 10 and runs vertically [0029]; The elongated slot allows a needle to be placed in Denonvilliers space at a desired angle [0009]; slot allows needle to be placed at various angles/heights that are different from each other).
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 needle holder device is movable within the central opening between a first path angle orientation and a second path angle orientation different than the first path angle orientation, as taught by Barzell, in order to achieve the template grid can be used in different configuration to suit the user's needs, as suggested by Barzell ([0014]).
Regarding claim 31, modified Allaway teaches the needle guidance device of claim 29, as discussed above. Allaway further teaches wherein the needle holder device (2712) is movable within the central opening between a first path height position of the needle holder device with respect to the longitudinal axis and a second path height position of the needle holder device with respect to the longitudinal axis different than the first path height position(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]; the needle can move between various heights that are parallel/ with respect to the longitudinal axis/length of the probe).
Regarding claim 36, Allaway teaches a method for performing a transperineal prostate biopsy on a patient using a needle guidance device (The biopsy guide may be configured to guide an access needle to perforate an access site in subcutaneous tissue of a perineum, whereby movement of the access needle is fixed relative to a movement of the transrectal transducer [0041]), said method comprising:
securing the needle holder device at the first path height position and the first path angle orientation (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]; the needle can move between various heights that are parallel/ with respect to he longitudinal axis/length of the probe).;
advancing a puncture device through a central aperture formed in the needle holder device in a distal direction relative to the guide tower to puncture a patient's perineum skin surface at a puncture site to obtain a first biopsy of a prostate at a first location using a biopsy needle advanced through the puncture device (The access needle may be configured to perforate and be positioned within subcutaneous tissue of a perineum at an access site of a target area of a patient…The access needle may be configured to extend into the subcutaneous tissue when the access needle is displaced to the distal end [0009]; ;
removing the biopsy needle with the first biopsy from the puncture device (Moreover, such systems and methods include extracting prostate tissue specimens by delivering separate punctures into the transperineal tissue [0039]; extracting tissue inherently requires removing the biopsy sample);
advancing the biopsy needle through the puncture device to obtain a second biopsy of the prostate at a second location different from the first location ((Moreover, such systems and methods include extracting prostate tissue specimens by delivering separate punctures into the transperineal tissue [0039]).
Allaway, however, does not teach
positioning a needle holder device within a first pair of aligned receiving channels of a plurality of aligned receiving channels formed on a guide tower of the needle guidance device at a first path height position of a plurality of path height positions and a first path angle orientation of a plurality of path angle orientations;
and with the puncture device positioned at the puncture site, pivotably moving the needle holder device within the first pair of aligned receiving channels from the first path angle orientation to a second path angle orientation of the plurality of path angle orientations.
Barzell is considered analogous to the instant application as “Template grid system” is disclosed (title).
Barzell teaches positioning a needle holder device (100 [0044]; fig. 11; template grid 100 has proximal and distal members 102, 104 that are removably coupled [0044]) within a first pair of aligned receiving channels of a plurality of aligned receiving channels (Passages 12 [0044]; when proximal and distal members 102, 104 are coupled, parallel placement of needles is achieved [0044]), formed on a guide tower of the needle guidance device at a first path height position of a plurality of path height positions and a first path angle orientation of a plurality of path angle orientations (slot 24 that has a length substantially larger than its width [0029]; The elongated slot allows a needle to be placed in Denonvilliers space at a desired angle; various heights/angles of the needle can be achieved as the needle can move across the slot that are on opposing portions of the guide tower 100),
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 positioning a needle holder device within a first pair of aligned receiving channels of a plurality of aligned receiving channels formed on a guide tower of the needle guidance device at a first path height position of a plurality of path height positions and a first path angle orientation of a plurality of path angle orientations,, as taught by Barzell, in order to allow for template grid can be used in different configuration to suit the user's needs, as suggested by Barzell ([0014]).
The combined invention still does not teach and with the puncture device positioned at the puncture site, pivotably moving the needle holder device within the first pair of aligned receiving channels from the first path angle orientation to a second path angle orientation of the plurality of path angle orientations.
Howlett is considered to be analogous to the claimed invention as an ultrasound imaging system and needle guidance system is disclosed ([0005]).
Howlett teaches: the puncture device positioned at the puncture site, pivotably moving the needle holder device within the first pair of aligned receiving channels from the first path angle orientation to a second path angle orientation of the plurality of path angle orientation ([0054] disclose positioning shoulders 92; molded transducer basket and needle guide holder which has a plurality of guide slots for achieving various angles and depths of penetration for accessing a vessel [0023]; the needle stays aligned with the respect to the center/longitudinal axis of the probe, the attachment with the probe 60 shown in fig. 8, and is positioned in an angle/pivotably).
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 puncture device positioned at the puncture site, pivotably moving the needle holder device within the first pair of aligned receiving channels from the first path angle orientation to a second path angle orientation of the plurality of path angle orientation, as taught by Howlett, in order to prevent inadvertent movement and/or removal of the needle, as suggested by Howlett ([0004]).
Regarding claim 37, modified Allaway teaches the method of claim 36, as discussed above. Allaway further teaches advancing a biopsy needle through the central aperture formed in the needle holder device in a distal direction relative to the guide tower to obtain a third biopsy of the prostate at a third location using a biopsy needle advanced through the puncture device (Moreover, such systems and methods include extracting prostate tissue specimens by delivering separate punctures into the transperineal tissue [0039]; multiple tissue extractions can take place).
Allaway, however, does not teach:
with the puncture device positioned at the puncture site, removing the needle holder device from within the first pair of aligned receiving channels;
positioning the needle holder device within a second pair of aligned receiving channels of a plurality of pairs of aligned receiving channels at a second path height position of the plurality of path height positions and a third path angle orientation of the plurality of path angle orientations; and
Barzell, however, teaches
with the puncture device positioned at the puncture site, removing the needle holder device from within the first pair of aligned receiving channels (The passages are sized to accommodate a medical implant such as needles [0009]; [0029]-[0030] disclose various positions where the needle can be positioned during a procedure)
positioning the needle holder device within a second pair of aligned receiving channels of a plurality of pairs of aligned receiving channels at a second path height position of the plurality of path height positions (Distal and proximal plates 114 and 116 are provided with a series of passages 12 sized to accommodate a medical implant such as needles. [0046]; needles can be placed in various heights as there are multiple positions) and a third path angle orientation of the plurality of path angle orientations ((The elongated slot allows a needle to be placed in Denonvilliers space at a desired angle [0009]; slot allows needle to be placed at various angles/heights).
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 with the puncture device positioned at the puncture site, removing the needle holder device from within the first pair of aligned receiving channels, positioning the needle holder device within a second pair of aligned receiving channels of a plurality of pairs of aligned receiving channels at a second path height position of the plurality of path height positions and a third path angle orientation of the plurality of path angle orientations, as taught by Barzell, in order to achieve the template grid can be used in different configuration to suit the user's needs, as suggested by Barzell ([0014]).
Regarding claim 39, modified Allaway teaches the method of claim 36, as discussed above. Allaway further teaches further comprising translating the guide tower in a distal direction relative to a base of the needle guidance device to puncture the patient's perineum skin surface at the puncture site (Atop each of the vertical extension members 2724 is a guide rail or stabilization bar 2726 that is adapted to slidingly engage with and allow the displacement member 2710 to translate along a trajectory that is parallel with the longitudinal axis 2720 of the guide member 2708 [0207]; As with previously described embodiments, the guide rails 2726 and, more particularly, the distal face 2740 of the guide rails 2726 may facilitate the positioning and holding of the perineal skin and subcutaneous tissue to allow positioning of the access needle 2712 [0208])
Claims 22, 23, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Allaway (US 20160022309 A1, of record) in view of Barzell et al. (US 20040143150 A1, hereinafter “Barzell”) and Howlett et al. (US 20130150714 A1, of record, hereinafter "Howlett"), and Nowlin et al (US 20080077089 A1, hereinafter "Nowlin").
Regarding claim 22, modified Allaway teaches needle guidance device of claim 21, as discussed above. Allaway, however, is silent regarding with the second portion coupled to the first portion, the second portion is configured to translate in a direction parallel to the longitudinal axis between a first position with respect to the first portion and a second position with respect to the first portion.
Nowlin is considered analogous to the instant application as “Detachable Grid” is disclosed (title). Nowlin teaches:
with the second portion (106) coupled (includes a base plate 102 that houses a first guide 104 and a second guide 106 [0025]) to the first portion (104), the second portion is configured to translate in a direction parallel to the longitudinal axis between a first position with respect to the first portion and a second position with respect to the first portion (The base plate 102 includes a central aperture 202 that is perpendicular to a longitudinal axis 212 of the base plate 102. When the guides 104, 106 are inserted into the base plate 102, the locations of the insertion apertures 204, 206 position the guides 104, 106 perpendicular to each other and the longitudinal axis 212 [0028]; the insertion apertures 208, 210 include tracks wherein the guides 108, 110 slide into and out of the base plate 102 [0029]; the second portion can translate an a direction perpendicular to the longitudinal axis, as shown in fig. 4).
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Fig. 4 of Nowlin 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 with the second portion coupled to the first portion, the second portion is configured to translate in a direction parallel to the longitudinal axis between a first position with respect to the first portion and a second position with respect to the first portion, as taught by Nowlin. Doing so would allow for accurate and flexible positioning of medical devices within a patient, as suggested by Nowlin ([0002]).
Regarding claim 23, modified Allaway teaches the needle guidance device of claim 21, as discussed above. Allaway, however, does not teach an alignment plate positionable within a slot formed transversely through at least a portion of the second portion, the alignment plate defining a path retaining channel configured to engage a path retaining element formed on the body to align the path retaining element with a pair of aligned receiving channels and retain the needle holder device in a parallel path orientation.
Nowlin is considered analogous to the instant application as “Detachable Grid” is disclosed (title). Nowlin teaches:
an alignment plate (104) positionable within a slot formed transversely through at least a portion of the second portion (As depicted in FIG. 2, the base plate 102 includes a first insertion aperture 204 that is located on a first edge 214 [0025]; The insertion apertures 204, 206 receive the guides 104, 106, thereby engaging the latter with the base plate 102 [0026]), the alignment plate defining a path retaining channel configured to engage a path retaining element formed on the body to align the path retaining element with a pair of aligned receiving channels and retain the needle holder device in a parallel path orientation (As depicted in FIG. 3, the first guide 104 typically includes spaced prongs 302. Each prong 302 is separated from its neighboring prong by a space 304, each space having a width and a length [0027]; Also, the apparatus and methods described above can be used in other applications such as, for example, guiding biopsy [0040]; while in the passages, the movement of the medical devices is limited to the direction of the passages, that is, in a direction parallel (i.e., coaxial) to the axis of the base plate [0009]).
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 teach an alignment plate positionable within a slot formed transversely through at least a portion of the second portion, the alignment plate defining a path retaining channel configured to engage a path retaining element formed on the body to align the path retaining element with a pair of aligned receiving channels and retain the needle holder device in a parallel path orientation, as taught by Nowlin. Doing so would allow for undesirable angular movement of the medical devices thus is minimized or eliminated by the apparatus, as suggested by Nowlin ([0009]).
Regarding claim 40, modified Allaway teaches the method of claim 36, as discussed above. Allaway, however, does not teach wherein securing the needle holder device at the first path angle orientation comprises clamping an alignment plate positioned in a slot formed in the guide tower to secure the needle holder device at the first path angle orientation.
Nowlin, however, teaches wherein securing the needle holder device at the first path angle orientation comprises clamping an alignment plate positioned in a slot formed in the guide tower to secure the needle holder device at the first path angle orientation (he guides, which in some embodiments are substantially planar, can include a series of parallel spaced prongs. Consequently, the perpendicular arrangement of the guides creates passages parallel (i.e., coaxial) to the axis of the base plate where the spaces between the prongs intersect at right angles. Medical devices then can be passed through these passages to their intended targets in the patient. While in the passages, the movement of the medical devices is limited to the direction of the passages, that is, in a direction parallel (i.e., coaxial) to the axis of the base plate [0009]; the right angle is the first path angle orientation as claimed)
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 securing the needle holder device at the first path angle orientation comprises clamping an alignment plate positioned in a slot formed in the guide tower to secure the needle holder device at the first path angle orientation, as taught by Nowlin. Doing so would allow for accurate and flexible positioning of medical devices within a patient, as suggested by Nowlin ([0002]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Allaway (US 20160022309 A1, of record) in view of Barzell et al. (US 20040143150 A1, hereinafter “Barzell”) and Howlett et al. (US 20130150714 A1, of record, hereinafter "Howlett"), and Pajunk et al. (DE 102010008491 B4, hereinafter "Pajunk", attached WIPO translation is used for citations below).
Regarding claim 24, modified Allaway teaches the needle guidance device of claim 21, as discussed above. Allaway, however, does not teach wherein the needle holder device is pivotably movable within a pair of aligned receiving channels of the plurality of pairs of aligned receiving channels at the respective distance between a first path angle with respect to the ultrasound probe and a second path angle with respect to the ultrasound probe different than the first path angle.
Pajunk is considered analogous to the instant application as “Pajunk discloses “Device for guiding a medical cannula on an ultrasound head” is disclosed (title). Pajunk teaches:
wherein the needle holder device (32) is pivotably movable within a pair of aligned receiving channels of the plurality of pairs of aligned receiving channels (pairs 26) at the respective distance between a first path angle with respect to the ultrasound probe and a second path angle with respect to the ultrasound probe different than the first path angle (The guide element 32 is then pivoted such that the axial direction of the inner bore 54 is aligned with the target area. In this angular position, the guide element 32 remains in the angle detents 26 due to the latching locking of the detent springs 42. [0039]; the needle holder device is pivotably movable between multiple positions and angles, as it attaches within the various parallel channels 26)
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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 wherein the needle holder device is pivotably movable within a pair of aligned receiving channels of the plurality of pairs of aligned receiving channels at the respective distance between a first path angle with respect to the ultrasound probe and a second path angle with respect to the ultrasound probe different than the first path angle, as taught by Pajunk. Doing so would achieve simple handling and alignment of the cannula/needle, as suggested by Pajunk ([0006]).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Allaway (US 20160022309 A1, of record) in view of Barzell et al. (US 20040143150 A1, hereinafter “Barzell”) and Howlett et al. (US 20130150714 A1, of record, hereinafter "Howlett"), Pajunk et al. (DE 102010008491 B4, hereinafter "Pajunk", attached WIPO translation is used for citations below), and Schlitt et al. (US 20100041990 A1, hereinafter “Schlitt”).
Regarding claim 25, modified Allaway teaches the needle guidance device of claim 24, as discussed above. Allaway, however, does not teach further comprising a knob operatively coupled to the needle holder device, the knob configured to secure the needle holder device at the first path angle.
Schlitt is considered analogous to the instant application as “Needle Guides for Catheter Delivery” is disclosed (title).
Schlitt teaches comprising a knob (226) operatively coupled to the needle holder device (224), the knob configured to secure the needle holder device at the first path angle (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 knob operatively coupled to the needle holder device, the knob configured to secure the needle holder device at the first path angle, as taught by Schlitt. Doing so would allow for many positioning possibilities, as suggested by Schlitt ([0050]).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Allaway (US 20160022309 A1, of record) in view of Barzell et al. (US 20040143150 A1, hereinafter “Barzell”) and Howlett et al. (US 20130150714 A1, of record, hereinafter "Howlett"), and Chisholm et al (US 20120253100 A1, hereinafter “Chisholm”).
Regarding claim 32, modified Allaway teaches the needle guidance device of claim 21, as discussed above. Allaway, however, does not teach wherein each of the first receiving channel and the second receiving channel is arcuately shaped.
Barzell, however, teaches each of the first receiving channel and the second receiving channel [has the same] shape (Passages 12 [0044]; when proximal and distal members 102, 104 are coupled, parallel placement of needles is achieved [0044]; each of the channels 112 are both parts of the second portion 102 and 104 are the same shape as shown in fig. 11).
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 each of the first receiving channel and the second receiving channel [has the same] shape, as taught by Barzell, in order to achieve the template grid can be used in different configuration to suit the user's needs, as suggested by Barzell ([0014]).
The combined invention, however, does not teach [wherein each of the first receiving channel and the second receiving channel] is arcuately shaped.
Chisholm is considered analogous to the instant application, as needle-based medical device is disclosed (abstract).
Chisholm teaches a channel that is arcuately shaped (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 channel 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]).
Claim 33 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Allaway (US 20160022309 A1, of record) in view of Barzell et al. (US 20040143150 A1, hereinafter “Barzell”) and Pajunk et al. (DE 102010008491 B4, hereinafter "Pajunk", attached WIPO translation is used for citations below)
Regarding claim 33, Allaway teaches:
a guide platform (a platform 2766 of the upper mount coupling mechanism 2714 of the lower mount 2704 [0212]) configured to removably couple to an ultrasound probe, the ultrasound probe having a length extending along a longitudinal axis of 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]; fastening mechanism is releasable, example disclosed in [0246])
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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 2702 extends along the longitudinal axis, annotated above).
Allaway, however, does not teach:
the guide tower comprising a frame at least partially defining a guidance slot and including a first pair of receiving channels aligned at a distance from the longitudinal axis; and
a needle holder device pivotably coupled to the first pair of receiving channels, the needle holder device pivotable about a rotational axis perpendicular to the longitudinal axis with respect to the guide tower to move the needle holder device from a first path angle orientation of a plurality of path angle orientations to a second path angle orientation of the plurality of path angle orientations different from the first path angle orientation, the needle holder device defining a central aperture therethrough configured to receive a needle.
Barzell is considered analogous to the instant application as “Template grid system” is disclosed (title).
Barzell teaches:
the guide tower comprising a frame (100 [0044]; fig. 11; template grid 100 has proximal and distal members 102, 104 that are removably coupled [0044]) at least partially defining a guidance slot (Slot 24 allows a needle to be placed in Denonvilliers space at a desired angle [0030]) and including a first pair of receiving channels aligned at a distance from the longitudinal axis (Passages 12 [0044]; when proximal and distal members 102, 104 are coupled, parallel placement of needles is achieved [0044]; [0034] further discloses that the channels 12 are parallel; [0005] discloses that the grid is in a fixed position with respect to an ultrasound probe).
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Fig.11 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 the guide tower comprising a frame at least partially defining a guidance slot and including a first pair of receiving channels aligned at a distance from the longitudinal axis, as taught by Barzell, in order to achieve the template grid can be used in different configuration to suit the user's needs, as suggested by Barzell ([0014]).
The combined invention is still silent regarding a needle holder device pivotably coupled to the first pair of receiving channels, the needle holder device pivotable about a rotational axis perpendicular to the longitudinal axis with respect to the guide tower to move the needle holder device from a first path angle orientation of a plurality of path angle orientations to a second path angle orientation of the plurality of path angle orientations different from the first path angle orientation, the needle holder device defining a central aperture therethrough configured to receive a needle.
Pajunk is considered analogous to the instant application as “Pajunk discloses “Device for guiding a medical cannula on an ultrasound head” is disclosed (title). Pajunk teaches:
a needle holder (32) device pivotably coupled to the first pair of receiving channels (pairs 26), the needle holder device pivotable about a rotational axis perpendicular to the longitudinal axis with respect to the guide tower to move the needle holder device from a first path angle orientation of a plurality of path angle orientations to a second path angle orientation of the plurality of path angle orientations different from the first path angle orientation, the needle holder device defining a central aperture therethrough configured to receive a needle (The guide element 32 is then pivoted such that the axial direction of the inner bore 54 is aligned with the target area. In this angular position, the guide element 32 remains in the angle detents 26 due to the latching locking of the detent springs 42. [0039]; the needle holder device is pivotably movable between multiple positions and angles, as it attaches within the various parallel channels 26).
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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 needle holder device pivotably coupled to the first pair of receiving channels, the needle holder device pivotable about a rotational axis perpendicular to the longitudinal axis with respect to the guide tower to move the needle holder device from a first path angle orientation of a plurality of path angle orientations to a second path angle orientation of the plurality of path angle orientations different from the first path angle orientation, the needle holder device defining a central aperture therethrough configured to receive a needle, as taught by Pajunk. Doing so would achieve simple handling and alignment of the cannula/needle, as suggested by Pajunk ([0006]).
Regarding claim 35, modified Allaway teaches the needle guidance device of claim 33, as discussed above. Allaway, however, does not teach a plurality of pairs of receiving channels located 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 and the needle holder device is configured to removably couple to each pair of aligned receiving channels of the plurality of pairs of receiving channels.
Pajunk, however, teaches a plurality of pairs of receiving channels (26; fig 1; channels 26 are parallel as shown in fig. 1) located at a plurality of path height positions (The jaws 20 of the holder 16 have on their curved outer edge a sector lateral surface 24 which extends in a circular arc shape over an angle of