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 .
Claims 1-17 are the currently pending claims hereby under examination.
Claim Objections
Claims 6, 9-12, and 16-17 are objected to because of the following informalities:
In claim 6, line 3: “to selectively the length of the extension arm” lacks a verb and should be revised to “to selectively adjust the length of the extension arm” or similar, for clarity;
In claims 9–11 and 16–17, line 1: “claim of claim” is a typographical error and should be corrected to “claim”;
In claim 9, line 4-5: “each leg member has an end … wherein one cannula clamp is disposed at an end of each leg portion” uses “leg portion” after introducing “leg member,” creating an inconsistent reference; revise “leg portion” to “leg member” for consistency;
In claim 12, lines 11-12: “wherein the second end of rigid extension arm being fixed at the spaced lateral distance from the cannula axis” is ungrammatical; revise to “wherein the second end of the rigid extension arm is fixed at the spaced lateral distance from the cannula axis”; and
In claim 12, line 14: “to selectively the length of the extension arm” lacks a verb and should be revised to “to selectively adjust the length of the extension arm”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites “wherein the cannula clamp includes a pair of spaced apertures in which a handle of the cannula is removably receivable to attach the cannula to the cannula handle assembly for conjoined movement with the cannula handle assembly” in lines 1-3. When read in light of the specification, which consistently describes and depicts a pair of spaced clamps, each individual clamp defining an aperture that receives the handle, located at the ends of leg members joined by a center portion, the phrase “the cannula clamp includes a pair of spaced apertures" is susceptible to at least two reasonable interpretations: (i) a single unitary clamp having 2 spaced apertures, or (ii) a pair of separate clamps, each having one aperture, collectively referred to as the cannula clamp. See e.g. [0033]: “In the representatively shown embodiment, body 24 has a pair of spaced clamps 26 … when joined define an aperture 28 in which the cannula handle 22 is received and retained” and [0035]: “As further shown, clamps 26 are disposed at the ends of spaced leg members 32 of the body 24” (see also figures 1-3 and 8). The Examiner is interpreting that claim 15 is meant to follow the pattern outlined in claim 8 (as well as the body of the specification), where each aperture/leg is/has its own clamp.
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.
Claims 1-7, 10, 12-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Zine et al. (US 20250176994 A1), hereto referred as Zine, and further in view of Cohen et al. (US 20190059940 A1), hereto referred as Cohen, and further in view of Girgenti et al. (US 20130072816 A1), hereto referred as Girgenti.
Regarding claim 1, Zine teaches that a medical imaging probe attachment apparatus comprises (Zine, Abstract: "An apparatus to guide movement of an insertable medical device... comprises a single plane articulated arm adapted to be affixed to an ultrasound transducer and configured to allow the adjustment of a medical device within a single displacement plane... of the ultrasound transducer", shows an attachment apparatus that holds and stabilizes the ultrasound transducer for imaging operations in relation to the insertion of a medical device): a probe holder assembly, the probe holder assembly having a probe attachment that is configured to removably attach an imaging probe to the probe holder assembly (Zine, FIG. 1, 21-22; ¶[0097]: “the mount 400 may comprise a transducer attaching mechanism 410, such as but not limited to a strap or to matching portions”, shows a transducer probe-side mount with a dedicated attaching mechanism that receives the transducer and provides a removable attachment interface to the probe; ¶[0104]: “the mount 400 may therefore comprise a suspension assembly 470 disposed between the mount 400 and the ultrasound transducer 200”, identifies a probe-side subassembly element interposed between the mount and the probe as part of the probe holder assembly; ¶[0100]: “the peripheral skirt 465 may facilitate the use of the articulated arm 100 and medical device 300”, confirms that the probe-side mount assembly (400 with associated features) operates in concert with the articulated arm 100 that couples upstream toward the slide 115 (i.e. rigid extension arm), so collectively the mount-side components (400/470) together with the articulated arm 100 function as the probe holder assembly that connects the probe to, but is distinct from, the rigid extension arm 115); with an imaging end of the imaging probe being located approximate to and facing in a direction toward a distal end of the cannula when the cannula is attached to the cannula handle assembly (Zine, FIG. 21: depicts the imaging probe end facing toward the distal tip of the medical device for co‑planar imaging guidance (Zine, Figs. 21–25), which corresponds to the claimed orientation of the imaging end facing toward the distal end of the cannula; ¶[0127]: “the curved edge 612 may allow a pivoting of the ultrasound transducer mount 600… providing a better view of the needle within the scanning plane 210”, this teaches the transducer mount positioning the imaging transducer relative to the needle (medical device) so that the imaging face views the needle, corresponding to the claimed orientation of the imaging end toward the distal end of the cannula).
Also regarding claim 1, Zine does not expressly teach that the apparatus comprises: a cannula handle assembly, the cannula handle assembly having a cannula clamp that is configured to removably attach a cannula to the cannula handle assembly for conjoined movement with the cannula handle assembly and with the cannula extending in a cannula direction outwardly from the cannula handle assembly along a cannula axis. Rather, Zine teaches that the attaching assembly provides guided manipulation of the medical device such that its motion is maintained in coordination with the supporting arm along a defined axis (the cannula direction). Specifically, Zine ¶[0121] states that the medical device movement is 'coplanar with the scanning plane 210,' and ¶[0071] describes maintaining the longitudinal axis of the medical device within a defined plane. Figures 21 and 22 depict the motion of the needle being parallel with the arm/slidable member and the assembly moving with the medical device (i.e. cannula with handle). These passages and figures demonstrate conjoined movement of the cannula/device and its assembly along a defined axis, consistent with movement along the cannula axis. However, Zine does not specifically teach a cannula handle assembly with clamps that receive a cannula handle and secure it. Instead, Zine only shows that the cannula/device attaches to the attaching assembly without clarifying a clamp type mechanism (Zine, ¶[0126]: “a user positions the device 600 over a zone where to insert the medical device and position the medical device 300 using the pivoting arm 620… the user moves the chariot 644 or triggers its movement to release the medical device 300 from the attaching assembly 640”; see also ¶[0080]-[0081]).
Cohen, however, provides this missing structural detail by expressly teaching “a mounting block, including a block body and a clamp configured to clamp the cannula handle at a selected longitudinal position relative to the block body” (Cohen, ¶[0079]). These passages disclose a positive locking clamp that secures a handled cannula to a mounting body while permitting selective release, matching the claimed removable cannula clamp.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zine in view of Cohen to incorporate Cohen’s clamp into Zine’s attaching assembly so as to provide a cannula handle assembly with a cannula clamp that removably clamps the cannula handle at a selected longitudinal position for conjoined movement along a cannula axis. The combination is straightforward and feasible, since Cohen’s clamp represents a known and routinely applied fastening approach for holding medical instruments on support structures. The benefit would be improved positional stability and repeatable alignment of the cannula with respect to the handle assembly while still allowing rapid attachment and removal during image-guided procedures, thereby enhancing accuracy, usability, and procedural safety.
Also regarding claim 1, Zine does not expressly teach that the apparatus comprises: a rigid extension arm having opposite first and second ends and a length extending therebetween, the rigid extension arm attached at its first end to the cannula handle assembly for conjoined movement with the cannula handle assembly, the rigid extension arm extending outwardly from the cannula handle assembly in cannula direction and at a spaced lateral distance from and parallel to the cannula axis. Rather, Zine teaches a laterally offset, parallel standoff that the attaching assembly rides along to move the medical device in a controlled manner, including a “slidable member 115” with a “longitudinal groove” that “receiv[es] a matching protrusion” and is “adapted to receive the attaching assembly 640” for translational guidance of the device (Zine, ¶[0092]–[0093]). These passages demonstrate that the attaching assembly and the slide are coordinated to move together in directions lateral to the sliding axis, providing only partial conjoined movement as there is slidablity between parts. Zine does not, however, describe whether the attaching assembly 640 can be locked onto the slidable member 115 to prevent movement along the slide axis, nor whether such locking would immobilize the components or simply maintain contact. Further, although Zine discloses a “locking mechanism 645” that secures the attaching assembly 640 to the articulated arm 100, it does not state that this same mechanism applies to the 640–115 interface or that it achieves rigid fixation between them (Zine, ¶[0083]). Zine likewise does not explicitly state that the slidable member 115 is rigid, but a person of ordinary skill in the art would recognize that rigidity would be necessary for proper operation, ensuring stable mechanical support and maintaining geometric alignment between the attaching assembly and the medical device during use.
While Zine discloses partial conjoined movement between the attaching assembly and the arm through guided lateral coordination, it does not show full fixation along the sliding axis. Girgenti provides the complementary structural locking mechanism that allows the assembly to be fixed at a selected position, thereby achieving complete conjoined movement between the rigid arm and the handle assembly. Girgenti discloses a rigid, laterally offset arm with “parallel rails 166” and an “X-axis slide lock” in which “locking features… allow the slide assembly to be secured in a desired position” and “fix… the slide assembly in a location that does not traverse the X-Axis,” demonstrating rigidity and positional locking in a parallel standoff geometry (Girgenti, [0034]: rails/locking features; [0035]: X-axis slide lock with “spring loaded locking plate 400… fix[ing] the slide assembly”). These passages demonstrate a rigid, lockable standoff structure maintaining parallel orientation and positional stability, features that would supply the rigid and fixed characteristics absent from Zine’s slidable member 115 and attaching assembly 640 interface allowing full conjoined movement.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zine in view of Girgenti to implement a rigid, end-fixed, lockable parallel standoff for the attaching assembly so that the extension arm is rigid and fixed at its end to the handle/body side while maintaining parallel, laterally offset guidance of the device. The combination is feasible because both systems use a laterally offset arm as a positioning standoff for image-guided instrument insertion; substituting Girgenti’s rigid, rail-and-lock construction into Zine’s slidable member is a predictable use of known rigidified, lockable rail standoffs to improve positional stability and repeatability. While Girgenti’s structure is not a handheld system designed for continuous conjoined movement, its rigid parallel rail and lockable carriage mechanism provide the specific structural features (rigidity, parallel offset, and positional locking) that Zine does not explicitly disclose. When incorporated into Zine’s articulated, mobile probe assembly, these features would allow the attaching assembly and arm to move as a single, conjoined unit when locked, thereby fulfilling the claimed relationship between the extension arm and handle assembly. The benefit is improved mechanical coupling and alignment between the imaging probe and cannula during coordinated movement of the assembly, ensuring that both components maintain a stable spatial relationship despite operator motion, thereby supporting accurate image guidance and reproducible targeting.
Regarding claim 2, Zine teaches that the probe holder assembly has an attachment fixture and a probe attachment subassembly (Zine, FIG. 21; ¶[0093]: “the articulated arm 100 comprises a slidable member or section 115… The slidable member 115 may be adapted to receive the attaching assembly 640”, the articulated arm 100 and its receiving interface operate as part of the attachment fixture that couples the probe-side subassembly to the slidable member 115; ¶[0097]: “the mount 400 may comprise a transducer attaching mechanism 410… a pivoting base 420… a rotation mechanism 430… and one or more adjustment knobs 440”, this identifies a composite structure making up a probe-attachment subassembly that supports and orients the ultrasound transducer 200 and couples with the "attachment fixture" 100); the attachment fixture being attached to the second end of the rigid extension arm for conjoined movement with the cannula handle assembly (Zine, ¶[0093]: “the articulated arm 100 comprises a slidable member or section 115… The slidable member 115 may be adapted to receive the attaching assembly 640”, here, although Zine describes 115 as a section of the articulated arm, for claim mapping it is treated as a distinct rigid extension arm entity interfacing with the attachment fixture at its second end; the structure thereby functions to move in concert with the cannula handle assembly; ¶[0084]: “The method may further comprise locking the articulated arm 100 at the set angle using the first hand of the operator”, showing that the articulated arm, and therefore the attached fixture and slidable member, can be locked into a fixed configuration that supports conjoined movement once positioned); the probe attachment subassembly being attached to the attachment fixture (Zine, FIG. 1B, 21–22: showing that the mount 400 couples to the articulated arm 100 through the upper section 470 of the transducer housing, illustrating an attachment interface between the probe-side subassembly (mount 400) and the fixture (articulated arm 100)); and the probe attachment subassembly having the probe attachment (Zine, FIG. 1B; ¶[0099]: “the mount 400 comprises two matching portions attachable to one another… when attached together, conform with the contour of the external surface of the transducer”, showing a subassembly that secures the transducer to the fixture via member 470).
Regarding claim 3, the combined Zine, Cohen, and Girgenti does not fully teach that the probe attachment subassembly is slidingly connected to the attachment fixture to allow selective positioning of the probe attachment subassembly relative to the attachment fixture. Rather, Zine provides vertical/plane-bound positioning via articulated arm 100 and joints (e.g., ¶[0073], ¶[0078]) but does not disclose a probe-side “slidingly connected” subassembly-to-fixture interface that allows selective positioning of the probe subassembly relative to the fixture.
Girgenti teaches a slide-and-couple arrangement that matches the missing relationship in Zine: clamp member 150 “can be slidably moved along and secured to the post member 106… [and] includes a threaded fastening member 152… for securing a distal end of the lateral arm 102 to the clamp member”, i.e., the clamp 150 is the sliding coupler, the post 106 is the subassembly it slides on, and the arm 102 is the attachment fixture, functionally corresponding to Zine's mount 400 slidingly connected to arm 100 to allow selective positioning (Girgenti, FIG. 4, ¶[0032]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zine in view of Girgenti to provide a sliding clamp-and-post style coupling between the probe-side subassembly and the attachment fixture to allow selective vertical positioning and secure locking of the subassembly relative to the fixture. Zine already provides the function of positioning the probe relative to the cannula equivalent via articulated arm 100, which demonstrates that Zine partially addresses the claimed feature and supports the rationale for incorporating Girgenti’s sliding mechanism. The combination is feasible because both systems utilize a laterally offset support member carrying an instrument mount, and substituting Girgenti’s clamp-on-post slide for Zine’s probe-side interface is a predictable use of a known sliding mechanism to achieve controlled, repeatable vertical adjustments. The benefit is improved vertical adjustability and stable fixation of the probe mount relative to the arm, enhancing alignment and ergonomics during image-guided procedures.
Regarding claim 4, Zine teaches that the probe attachment subassembly has a float member and a guide member, the float member has the probe attachment, the float member is operatively connected to the guide member such that the float member is capable of constrained up and down movement along a direction toward and away from the cannula axis (Zine, FIG. 52: illustration of the suspension assembly 470 positioned between the mount 400 and the probe structure shows vertical suspension members 472 and elastic components 474 acting as guides and float elements, enabling constrained up‑and‑down motion of the transducer, corresponding directly to the claimed float and guide member relationship; ¶[0104], “the mount 400 may therefore comprise a suspension assembly 470 disposed between the mount 400 and the ultrasound transducer 200… the suspension assembly 470 is generally configured to maintain a desirable level of pressure on the patient's member under examination… the suspension assembly 470 may therefore prevent excess pressure between the ultrasound transducer 200 and the surface of the patient's skin”, the suspension assembly 470 acts as a float structure between the probe and mount that limits pressure and enables controlled compliance normal to the skin consistent with constrained up and down movement; ¶[0105], “the suspension assembly 470 may comprise vertical suspension members and horizontal suspension members. The vertical suspension members may reduce the pressure generated by a vertical force applied to the mount 400”, the explicit vertical suspension members provide the guided, constrained vertical compliance consistent with a float member operatively connected to a guide member for movement toward and away from the cannula axis).
Regarding claim 5, Zine teaches that the float member is spring biased in a direction toward the cannula axis (Zine, ¶[0104]: “the suspension assembly 470 may comprise a spring, an air suspension assembly, a magnetic suspension assembly, or any other suitable system for the storage of mechanical energy”, this expressly teaches a spring within the suspension/float structure providing a biasing force normal to the patient surface, which corresponds to a bias toward the cannula axis under the broadest reasonable interpretation of up‑down movement relative to the device axis; ¶[0104]: “the suspension assembly 470 is generally configured to maintain a desirable level of pressure on the patient's member under examination… the suspension assembly 470 may therefore prevent excess pressure between the ultrasound transducer 200 and the surface of the patient's skin”, shows that the spring‑based suspension applies controlled pressure in the normal (toward/away) direction, evidencing a spring‑biased condition consistent with the claimed bias toward the cannula axis; ¶[0105]: “the suspension assembly 470 may comprise vertical suspension members… The vertical suspension members may reduce the pressure generated by a vertical force applied to the mount 400”, confirms the bias acts along the vertical/up‑down direction toward and away from the axis, consistent with a spring‑biased float member).
Regarding claim 6, Zine teaches that the rigid extension arm is adjustably connected at its first end to the cannula handle assembly to selectively adjust the length of the extension arm extending from the cannula handle assembly (Zine, FIGS. 21–22, ¶[0092]: “an embodiment of the attachment mechanism 640 comprising a slidable member 115 is illustrated… The slidable member 115 generally allows the medical device to move toward or away the subject or transducer… The slidable member 115 may comprise a longitudinal groove receiving a matching protrusion of the attachment mechanism 640 or of the medical device 300”, the 115↔640 groove/protrusion engagement provides an adjustable interface at the arm–assembly junction such that sliding changes the effective length of the arm that projects from the handle assembly analog; FIGS. 23–25, ¶[0093]: “the articulated arm 100 comprises a slidable member or section 115… The slidable member 115 may be adapted to receive the attaching assembly 640, thus giving the articulated arm 100 a further translational degree of freedom which may be used, for example, to move or insert the medical device 300 into a body portion of the patient”, receipt of 640 by 115 and the added translational DOF show that the arm’s extension relative to the assembly is selectively adjustable along the arm’s length, i.e., selecting the effective length extending from the assembly).
Regarding claim 7, Zine teaches that the first end of the rigid extension arm is slidingly disposed in a bore formed in the cannula handle assembly (Zine, ¶[0092]: “the slidable member 115 may comprise a longitudinal groove receiving a matching protrusion of the attachment mechanism 640 or of the medical device 300”, the groove and protrusion act as the bore‑and‑sliding engagement between the articulated arm (extension arm equivalent) and the attaching assembly 640 (cannula handle assembly equivalent), showing the arm’s first end slidingly disposed in the bore‑like structure of 640; ¶[0093]: “the slidable member 115 may be adapted to receive the attaching assembly 640, thus giving the articulated arm 100 a further translational degree of freedom”, this indicates that the slidable member 115 receives 640 in a manner that allows translation, supporting the sliding connection within a bore‑type interface), but does not teach that it further comprises an extension arm clamp that operates to clamp the first end in position in the bore. Rather, Zine teaches a sliding reception between the articulated arm section and the attaching assembly, i.e., a bore‑and‑protrusion style interface that enables translation, but Zine does not expressly teach an arm‑end clamp that fixes the position within that bore along the sliding axis. Zine discloses a “locking mechanism 645” that secures the attaching assembly 640 to the articulated arm 100, but it is unclear whether that lock applies to the slidable member 115 interface or whether it fixes position along the sliding axis in a bore‑clamping manner (Zine, ¶[0083]).
Girgenti teaches the missing clamp‑at‑bore feature. Girgenti provides explicit slide‑lock features on a sliding carriage over parallel rails: “Parallel rails 166… The slide assembly 110… allow the slide assembly to slidably move… Locking features… allow the slide assembly to be secured in a desired position… including an X‑Axis slide lock… fix the slide assembly in a location that does not traverse the X‑Axis” (Girgenti, [0034]–[0035]). Girgenti’s X-axis slide lock functions as a clamp by using cam-actuated locking plates that press against the rails to create frictional restraint, thereby fixing the slide assembly’s position; a clamping action equivalent to that required to hold the extension arm within its bore.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Zine, Cohen, and Girgenti in view of Girgenti to provide an extension‑arm clamp that operates to clamp the first end in position in the bore. The combination is feasible because both references employ a laterally offset arm received by a mating guide (bore/rail) to position a procedure instrument; substituting Girgenti’s clamp at the Zine arm–assembly sliding interface is a predictable use of known clamp‑and‑lock hardware on a sliding reception. One of ordinary skill in the art would have recognized that adapting Girgenti’s clamp member and locking features to Zine’s groove‑and‑protrusion reception would allow selecting and fixing the arm position along the slide, achieving full conjoined movement once locked. The benefit is improved positional stability and repeatability at the arm–assembly junction, reducing unintended drift during imaging‑guided insertion and maintaining a stable spatial relationship between the probe and the cannula‑equivalent during use.
Regarding claim 10, Zine teaches that the probe attachment has a probe clamp that is configured to removably attach the imaging probe to the probe holder assembly (Zine, ¶[0097]: “the mount 400 may comprise a transducer attaching mechanism 410, such as but not limited to a strap or to matching portions”, identifies a discrete attaching mechanism on the probe‑side mount that functions as a clamp by securing the imaging transducer to the mount while permitting selective attachment and removal consistent with a removable probe clamp on a probe holder assembly; ¶[0099]: “the mount 400 comprises two matching portions attachable to one another… when attached together, conform with the contour of the external surface of the transducer”, teaches a two‑part, attachable interface that grips the transducer housing to secure it to the mount, which corresponds to a clamp that removably attaches the imaging probe to the probe holder assembly; additionally ¶[0138]: “the calibration device 700 comprises a plurality of holding points 710 to attach the calibration device 700 to the body 610 of the transducer 600. The holding points 710 may be embodied as screws with rubber tips…”, teaches a fastening structure integrated within the probe assembly that engages the transducer body by compressive friction for calibration and positional alignment, demonstrating the same clamping principle used to removably attach the imaging probe to the probe holder assembly since the rubber‑tipped screws can be tightened to secure or loosened to release the probe).
Regarding claim 12, Zine teaches that a medical imaging probe attachment apparatus comprises (Zine, Abstract: "An apparatus to guide movement of an insertable medical device... comprises a single plane articulated arm adapted to be affixed to an ultrasound transducer and configured to allow the adjustment of a medical device within a single displacement plane... of the ultrasound transducer", shows an attachment apparatus that holds and stabilizes the ultrasound transducer for imaging operations in relation to the insertion of a medical device): a probe holder assembly, the probe holder assembly having a probe attachment that is configured to removably attach an imaging probe to the probe holder assembly (Zine, FIG. 1, 21-22; ¶[0097]: “the mount 400 may comprise a transducer attaching mechanism 410, such as but not limited to a strap or to matching portions”, shows a transducer probe-side mount with a dedicated attaching mechanism that receives the transducer and provides a removable attachment interface to the probe; ¶[0104]: “the mount 400 may therefore comprise a suspension assembly 470 disposed between the mount 400 and the ultrasound transducer 200”, identifies a probe-side subassembly element interposed between the mount and the probe as part of the probe holder assembly; ¶[0100]: “the peripheral skirt 465 may facilitate the use of the articulated arm 100 and medical device 300”, confirms that the probe-side mount assembly (400 with associated features) operates in concert with the articulated arm 100 that couples upstream toward the slide 115 (i.e. rigid extension arm), so collectively the mount-side components (400/470) together with the articulated arm 100 function as the probe holder assembly that connects the probe to, but is distinct from, the rigid extension arm 115); with an imaging end of the imaging probe being located approximate to and facing in a direction toward a distal end of the cannula when the cannula is attached to the cannula handle assembly (Zine, FIG. 21: depicts the imaging probe end facing toward the distal tip of the medical device for co‑planar imaging guidance (Zine, Figs. 21–25), which corresponds to the claimed orientation of the imaging end facing toward the distal end of the cannula; ¶[0127]: “the curved edge 612 may allow a pivoting of the ultrasound transducer mount 600… providing a better view of the needle within the scanning plane 210”, this teaches the transducer mount positioning the imaging transducer relative to the needle (medical device) so that the imaging face views the needle, corresponding to the claimed orientation of the imaging end toward the distal end of the cannula); wherein the second end of rigid extension arm being fixed at the spaced lateral distance from the cannula axis (Zine, FIG. 21-22: depicts the axis of the device (cannula axis) at a spaced lateral distance from the axis of the slidable member 115 (rigid extension arm) and thus its second end as it traverses the length of the slide/arm); wherein the rigid extension arm is adjustably connected at its first end to the cannula handle assembly to selectively the length of the extension arm extending from the cannula handle assembly (Zine, FIGS. 21–22, ¶[0092]: “an embodiment of the attachment mechanism 640 comprising a slidable member 115 is illustrated… The slidable member 115 generally allows the medical device to move toward or away the subject or transducer… The slidable member 115 may comprise a longitudinal groove receiving a matching protrusion of the attachment mechanism 640 or of the medical device 300”, the 115↔640 groove/protrusion engagement provides an adjustable interface at the arm–assembly junction such that sliding changes the effective length of the arm that projects from the handle assembly analog; FIGS. 23–25, ¶[0093]: “the articulated arm 100 comprises a slidable member or section 115… The slidable member 115 may be adapted to receive the attaching assembly 640, thus giving the articulated arm 100 a further translational degree of freedom which may be used, for example, to move or insert the medical device 300 into a body portion of the patient”, receipt of 640 by 115 and the added translational DOF show that the arm’s extension relative to the assembly is selectively adjustable along the arm’s length, i.e., selecting the effective length extending from the assembly).
Also regarding claim 12, Zine does not expressly teach that the apparatus comprises: a cannula handle assembly, the cannula handle assembly having a cannula clamp that is configured to removably attach a cannula to the cannula handle assembly for conjoined movement with the cannula handle assembly and with the cannula extending in a cannula direction outwardly from the cannula handle assembly along a cannula axis. Rather, Zine teaches that the attaching assembly provides guided manipulation of the medical device such that its motion is maintained in coordination with the supporting arm along a defined axis (the cannula direction). Specifically, Zine ¶[0121] states that the medical device movement is 'coplanar with the scanning plane 210,' and ¶[0071] describes maintaining the longitudinal axis of the medical device within a defined plane. Figures 21 and 22 depict the motion of the needle being parallel with the arm/slidable member and the assembly moving with the medical device (i.e. cannula with handle). These passages and figures demonstrate conjoined movement of the cannula/device and its assembly along a defined axis, consistent with movement along the cannula axis. However, Zine does not specifically teach a cannula handle assembly with clamps that receive a cannula handle and secure it. Instead, Zine only shows that the cannula/device attaches to the attaching assembly without clarifying a clamp type mechanism (Zine, ¶[0126]: “a user positions the device 600 over a zone where to insert the medical device and position the medical device 300 using the pivoting arm 620… the user moves the chariot 644 or triggers its movement to release the medical device 300 from the attaching assembly 640”; see also ¶[0080]-[0081]).
Cohen, however, provides this missing structural detail by expressly teaching “a mounting block, including a block body and a clamp configured to clamp the cannula handle at a selected longitudinal position relative to the block body” (Cohen, ¶[0079]). These passages disclose a positive locking clamp that secures a handled cannula to a mounting body while permitting selective release, matching the claimed removable cannula clamp.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zine in view of Cohen to incorporate Cohen’s clamp into Zine’s attaching assembly so as to provide a cannula handle assembly with a cannula clamp that removably clamps the cannula handle at a selected longitudinal position for conjoined movement along a cannula axis. The combination is straightforward and feasible, since Cohen’s clamp represents a known and routinely applied fastening approach for holding medical instruments on support structures. The benefit would be improved positional stability and repeatable alignment of the cannula with respect to the handle assembly while still allowing rapid attachment and removal during image-guided procedures, thereby enhancing accuracy, usability, and procedural safety.
Also regarding claim 12, Zine does not expressly teach that the apparatus comprises: a rigid extension arm having opposite first and second ends and a length extending therebetween, the rigid extension arm attached at its first end to the cannula handle assembly for conjoined movement with the cannula handle assembly, the rigid extension arm extending outwardly from the cannula handle assembly in cannula direction and at a spaced lateral distance from and parallel to the cannula axis. Rather, Zine teaches a laterally offset, parallel standoff that the attaching assembly rides along to move the medical device in a controlled manner, including a “slidable member 115” with a “longitudinal groove” that “receiv[es] a matching protrusion” and is “adapted to receive the attaching assembly 640” for translational guidance of the device (Zine, ¶[0092]–[0093]). These passages demonstrate that the attaching assembly and the slide are coordinated to move together in directions lateral to the sliding axis, providing only partial conjoined movement as there is slidablity between parts. Zine does not, however, describe whether the attaching assembly 640 can be locked onto the slidable member 115 to prevent movement along the slide axis, nor whether such locking would immobilize the components or simply maintain contact. Further, although Zine discloses a “locking mechanism 645” that secures the attaching assembly 640 to the articulated arm 100, it does not state that this same mechanism applies to the 640–115 interface or that it achieves rigid fixation between them (Zine, ¶[0083]). Zine likewise does not explicitly state that the slidable member 115 is rigid, but a person of ordinary skill in the art would recognize that rigidity would be necessary for proper operation, ensuring stable mechanical support and maintaining geometric alignment between the attaching assembly and the medical device during use.
While Zine discloses partial conjoined movement between the attaching assembly and the arm through guided lateral coordination, it does not show full fixation along the sliding axis. Girgenti provides the complementary structural locking mechanism that allows the assembly to be fixed at a selected position, thereby achieving complete conjoined movement between the rigid arm and the handle assembly. Girgenti discloses a rigid, laterally offset arm with “parallel rails 166” and an “X-axis slide lock” in which “locking features… allow the slide assembly to be secured in a desired position” and “fix… the slide assembly in a location that does not traverse the X-Axis,” demonstrating rigidity and positional locking in a parallel standoff geometry (Girgenti, [0034]: rails/locking features; [0035]: X-axis slide lock with “spring loaded locking plate 400… fix[ing] the slide assembly”). These passages demonstrate a rigid, lockable standoff structure maintaining parallel orientation and positional stability, features that would supply the rigid and fixed characteristics absent from Zine’s slidable member 115 and attaching assembly 640 interface allowing full conjoined movement.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zine in view of Girgenti to implement a rigid, end-fixed, lockable parallel standoff for the attaching assembly so that the extension arm is rigid and fixed at its end to the handle/body side while maintaining parallel, laterally offset guidance of the device. The combination is feasible because both systems use a laterally offset arm as a positioning standoff for image-guided instrument insertion; substituting Girgenti’s rigid, rail-and-lock construction into Zine’s slidable member is a predictable use of known rigidified, lockable rail standoffs to improve positional stability and repeatability. While Girgenti’s structure is not a handheld system designed for continuous conjoined movement, its rigid parallel rail and lockable carriage mechanism provide the specific structural features (rigidity, parallel offset, and positional locking) that Zine does not explicitly disclose. When incorporated into Zine’s articulated, mobile probe assembly, these features would allow the attaching assembly and arm to move as a single, conjoined unit when locked, thereby fulfilling the claimed relationship between the extension arm and handle assembly. The benefit is improved mechanical coupling and alignment between the imaging probe and cannula during coordinated movement of the assembly, ensuring that both components maintain a stable spatial relationship despite operator motion, thereby supporting accurate image guidance and reproducible targeting.
Regarding claim 13, Zine teaches that the probe holder assembly has an attachment fixture and a probe attachment subassembly (Zine, FIG. 21; ¶[0093]: “the articulated arm 100 comprises a slidable member or section 115… The slidable member 115 may be adapted to receive the attaching assembly 640”, the articulated arm 100 and its receiving interface operate as part of the attachment fixture that couples the probe-side subassembly to the slidable member 115; ¶[0097]: “the mount 400 may comprise a transducer attaching mechanism 410… a pivoting base 420… a rotation mechanism 430… and one or more adjustment knobs 440”, this identifies a composite structure making up a probe-attachment subassembly that supports and orients the ultrasound transducer 200 and couples with the "attachment fixture" 100); an attachment fixture being attached to the second end of the rigid extension arm for conjoined movement with the cannula handle assembly (Zine, ¶[0093]: “the articulated arm 100 comprises a slidable member or section 115… The slidable member 115 may be adapted to receive the attaching assembly 640”, here, although Zine describes 115 as a section of the articulated arm, for claim mapping it is treated as a distinct rigid extension arm entity interfacing with the attachment fixture at its second end; the structure thereby functions to move in concert with the cannula handle assembly; ¶[0084]: “The method may further comprise locking the articulated arm 100 at the set angle using the first hand of the operator”, showing that the articulated arm, and therefore the attached fixture and slidable member, can be locked into a fixed configuration that supports conjoined movement once positioned); the probe attachment subassembly being attached to the attachment fixture (Zine, FIG. 1B, 21–22: showing that the mount 400 couples to the articulated arm 100 through the upper section 470 of the transducer housing, illustrating an attachment interface between the probe-side subassembly (mount 400) and the fixture (articulated arm 100)); and the probe attachment subassembly having the probe attachment (Zine, FIG. 1B; ¶[0099]: “the mount 400 comprises two matching portions attachable to one another… when attached together, conform with the contour of the external surface of the transducer”, showing a subassembly that secures the transducer to the fixture via member 470).
Also regarding claim 12, Zine does not fully teach that the probe attachment subassembly is slidingly connected to the attachment fixture to allow selective positioning of the probe attachment subassembly relative to the attachment fixture. Zine provides vertical/plane-bound positioning via articulated arm 100 and joints (e.g., ¶[0073], ¶[0078]) but does not disclose a probe-side “slidingly connected” subassembly-to-fixture interface that allows selective positioning of the probe subassembly relative to the fixture.
Girgenti teaches a slide-and-couple arrangement that matches the missing relationship in Zine: clamp member 150 “can be slidably moved along and secured to the post member 106… [and] includes a threaded fastening member 152… for securing a distal end of the lateral arm 102 to the clamp member”, i.e., the clamp 150 is the sliding coupler, the post 106 is the subassembly it slides on, and the arm 102 is the attachment fixture, functionally corresponding to Zine's mount 400 slidingly connected to arm 100 to allow selective positioning (Girgenti, FIG. 4, ¶[0032]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zine in view of Girgenti to provide a sliding clamp-and-post style coupling between the probe-side subassembly and the attachment fixture to allow selective vertical positioning and secure locking of the subassembly relative to the fixture. Zine already provides the function of positioning the probe relative to the cannula equivalent via articulated arm 100, which demonstrates that Zine partially addresses the claimed feature and supports the rationale for incorporating Girgenti’s sliding mechanism. The combination is feasible because both systems utilize a laterally offset support member carrying an instrument mount, and substituting Girgenti’s clamp-on-post slide for Zine’s probe-side interface is a predictable use of a known sliding mechanism to achieve controlled, repeatable vertical adjustments. The benefit is improved vertical adjustability and stable fixation of the probe mount relative to the arm, enhancing alignment and ergonomics during image-guided procedures.
Regarding claim 14, Zine teaches that the probe attachment subassembly has a float member and a guide member, the float member has the probe attachment, the float member is operatively connected to the guide member such that the float member is capable of constrained up and down movement along a direction toward and away from the cannula axis (Zine, FIG. 52: illustration of the suspension assembly 470 positioned between the mount 400 and the probe structure shows vertical suspension members 472 and elastic components 474 acting as guides and float elements, enabling constrained up‑and‑down motion of the transducer, corresponding directly to the claimed float and guide member relationship; ¶[0104], “the mount 400 may therefore comprise a suspension assembly 470 disposed between the mount 400 and the ultrasound transducer 200… the suspension assembly 470 is generally configured to maintain a desirable level of pressure on the patient's member under examination… the suspension assembly 470 may therefore prevent excess pressure between the ultrasound transducer 200 and the surface of the patient's skin”, the suspension assembly 470 acts as a float structure between the probe and mount that limits pressure and enables controlled compliance normal to the skin consistent with constrained up and down movement; ¶[0105], “the suspension assembly 470 may comprise vertical suspension members and horizontal suspension members. The vertical suspension members may reduce the pressure generated by a vertical force applied to the mount 400”, the explicit vertical suspension members provide the guided, constrained vertical compliance consistent with a float member operatively connected to a guide member for movement toward and away from the cannula axis); and wherein the float member is spring biased in a direction toward the cannula axis (Zine, ¶[0104]: “the suspension assembly 470 may comprise a spring, an air suspension assembly, a magnetic suspension assembly, or any other suitable system for the storage of mechanical energy”, this expressly teaches a spring within the suspension/float structure providing a biasing force normal to the patient surface, which corresponds to a bias toward the cannula axis under the broadest reasonable interpretation of up‑down movement relative to the device axis; ¶[0104]: “the suspension assembly 470 is generally configured to maintain a desirable level of pressure on the patient's member under examination… the suspension assembly 470 may therefore prevent excess pressure between the ultrasound transducer 200 and the surface of the patient's skin”, shows that the spring‑based suspension applies controlled pressure in the normal (toward/away) direction, evidencing a spring‑biased condition consistent with the claimed bias toward the cannula axis; ¶[0105]: “the suspension assembly 470 may comprise vertical suspension members… The vertical suspension members may reduce the pressure generated by a vertical force applied to the mount 400”, confirms the bias acts along the vertical/up‑down direction toward and away from the axis, consistent with a spring‑biased float member).
Regarding claim 16, Zine teaches that the probe attachment has a probe clamp that is configured to removably attach the imaging probe to the probe holder assembly (Zine, ¶[0097]: “the mount 400 may comprise a transducer attaching mechanism 410, such as but not limited to a strap or to matching portions”, identifies a discrete attaching mechanism