DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s argument on Page 13 regarding the objection to the drawings has been fully considered. The objection to the drawings is withdrawn in view of the amendments.
Applicant’s argument on Page 13 regarding the objection the specification has been fully considered. The objection to the specification is withdrawn in view of the amendments.
Applicant’s argument on Page 13 regarding the claim interpretation has been fully considered. The claim interpretation is withdrawn in view of the amendments.
Applicant’s argument on Page 13 regarding the rejection of Claims 2, 4-6, 13, and 16 under 35 U.S.C. 112(a) has been fully considered. The rejection of Claims 2, 4-6, 13, and 16 under 35 U.S.C. 112(a) is withdrawn in view of the amendment.
Applicant’s argument on Page 13 regarding the rejection of Claims 2 and 4 under 35 U.S.C. 112(b) has been fully considered. The rejection of Claims 2 and 4 under 35 U.S.C. 112(b) is withdrawn in view of the amendment.
Applicant’s argument on Pages 13-14 regarding the rejection of Claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Zijlstra has been fully considered but is not persuasive under new grounds of rejection as below.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted on Page 14 relies on the supposed deficiencies with respect to the rejection of parent Claim 1. Applicant’s argument is moot for the same reasons detailed above.
Claim Objections
Claim 1 is objected to because of the following informalities: typographical error. The claim should be amended to “remov[[e]]ably.” Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 1-2, 4-6, 9-10, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen et al. (WO 2021236348) in view of Cermak (US 20160128719).
Regarding Claim 1, Hansen teaches a system for affixing an ultrasound transducer to a patient, (Abstract “A guide structure (10) is configured for placement on a patient's skin and holding a medical probe (61) for adjustable positioning over the patient's skin during vascular line placement.”), the system comprising:
a) one or more base component, ([0039] “base 12,” and [0076] “limb restraint 176”), defining an aperture, ([0039] “medical probe holder 61”), wherein the one or more base component is configured to be removeably [sic] affixed to the patient near or adjacent to a target patient anatomy, wherein the aperture includes a patient-facing opening and a user-facing opening (Abstract “during vascular line placement,” which one of ordinary skill in the art would understand that the device is removable when not being utilized for the procedure, and Fig. 8);
b) the ultrasound transducer, ([0039] “Fig. 1 A is a top plan view showing an embodiment of an ultrasound-guided intravenous placement guide structure 10 having a base 12 configured to rest on a patient’s skin. […] a medical probe 61 (Figs. 5, 6, and 8) placed in medical probe holder 60.” Where one of ordinary skill in the art would understand that a transducer is a standard component of an ultrasound medical probe.), wherein the ultrasound transducer is configured for a user of the system to one or more of move, position, re-position, orient, or re-orient, the ultrasound transducer within the aperture of the one or more base component, ([0040] “a carriage translation actuator 62 is operatively associated with undercarriage 52 to move carriage 50 along first carriage guide surface 40 and second carriage guide surface 42 and thereby adjust the position of the medical probe placed in medical probe holder 60 over the surface of a patient’s skin on which base 12 has been set and secured in place.”), and wherein the system is configured for the user to choose or select where to couple the ultrasound transducer to one or more of the base component, the patient, a patient contact surface, or the target patient anatomy ([0040] “a carriage translation actuator 62 is operatively associated with undercarriage 52 to move carriage 50 along first carriage guide surface 40 and second carriage guide surface 42 and thereby adjust the position of the medical probe placed in medical probe holder 60 over the surface of a patient’s skin on which base 12 has been set and secured in place” and [0045] “mutually spaced-apart hollows 114 are positioned at discrete intervals along the length of medical device holder 60 to receive carriage post fastener 112 inserted into carriage post through- hole 110 and thereby provide for selective adjustment of the portion of medical probe 61 into open space 18 to a desired distance from the skin of the patient.”); and
c) one or more securing component interfacing with the ultrasound transducer and the one or more base component, configured to (a) attach the ultrasound transducer to the one or more base component, (Fig. 1A and [0039] “first arm 14 and a second arm 16 […]. […] Carriage post 54 has a notch 59 that is configured to receive a medical probe holder 60” and [0040] “a carriage translation actuator 62 is operatively associated with undercarriage 52 to move carriage 50 along first carriage guide surface 40 and second carriage guide surface 42 and thereby adjust the position of the medical probe placed in medical probe holder 60 over the surface of a patient’s skin on which base 12 has been set and secured in place.”), and (b) substantially maintain contact of said ultrasound transducer and with one or more of the patient, the patient contact surface, or the target patient anatomy ([0039] “Tightening a flat-tipped pressure screw 61s passing through carriage post 54 secures in place medical probe holder 60 and thus medical probe 61 at the desired distance.”).
However, Hansen does not explicitly teach one or more base component defining an aperture such that the aperture provides user access to insert a needle, a probe, or an injectable device, through the aperture, into the patient, and into or towards the target patient anatomy.
In an analogous mounted needle guide field of endeavor, Cermak teaches a system, (Abstract “needle guide device”), the system comprising: one or more base component, ([0064] “adaptor bracket 200”), defining an aperture such that the aperture provides user access to insert a needle, a probe, or an injectable device, through the aperture, into the patient, and into or towards the target patient anatomy ([0064] “reusable needle guide device 20”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Hansen with Cermak because the modification ensures that the direction of the needle is adequate and secure, as taught by Cermak in [0003] and [0006].
Regarding Claim 2, the modified system of Hansen teaches all limitations of Claim 1, as discussed above. Furthermore, Hansen teaches wherein the one or more securing component is configured for adjusting a position of the ultrasound transducer that allows for moving the ultrasound transducer at least one of: up-and-down, ([0043] “The operative association of carriage translation actuator 62 and carriage 50 includes coupling of actuator shaft 78 to follower shaft 84 to, in response to a rotational force applied to actuator shaft 78, rotate them in opposite directions and thereby move carriage 50 in either direction along the lengths of gear racks 72 and 76 to adjust the position of a medical probe over the surface of a patient’s skin on which base 12 has been set and secured in place.”), left-and-right, diagonally across the patient contact surface, and at an angle relative to the patient contact surface ([0053] “carriage post 54 has a mounting arm 210 that is pivotally connected at its distal end to medical probe holder 60 for movement about a pivot axis 212.”).
Regarding Claim 4, the modified system of Hansen teaches all limitations of Claim 1, as discussed above. Furthermore, Hansen teaches wherein the one or more securing component is in operable communication with a positioning apparatus, the positioning apparatus configured to be manipulable by the user to substantially maintain, or optionally set, an ultrasound transducer angulation relative to the target ([0040] “a carriage translation actuator 62 is operatively associated with undercarriage 52 to move carriage 50 along first carriage guide surface 40 and second carriage guide surface 42 and thereby adjust the position of the medical probe placed in medical probe holder 60 over the surface of a patient’s skin on which base 12 has been set and secured in place,” [0043] “The operative association of carriage translation actuator 62 and carriage 50 includes coupling of actuator shaft 78 to follower shaft 84 to, in response to a rotational force applied to actuator shaft 78, rotate them in opposite directions and thereby move carriage 50 in either direction along the lengths of gear racks 72 and 76 to adjust the position of a medical probe over the surface of a patient’s skin on which base 12 has been set and secured in place,” and [0053] “carriage post 54 has a mounting arm 210 that is pivotally connected at its distal end to medical probe holder 60 for movement about a pivot axis 212.”).
Regarding Claim 5, the modified system of Hansen teaches all limitations of Claim 1, as discussed above. Furthermore, Hansen teaches wherein the one or more securing component comprises one or more of a band, a clip, a track, ([0041] “first gear rack 72 […] second gear rack 76”), a strap, (Figs. 4B and 9), or an adhesive.
Regarding Claim 6, the modified system of Hansen teaches all limitations of Claim 5, as discussed above. Furthermore, Hansen teaches wherein the track comprises at least two elongated members extending between two base components of the one or more base component, wherein the at least two elongated members are positioned substantially parallel to one another, (Figs. 1A and 1B, where the racks 72, 76 are contained within arms 14, 16), and wherein the at least two elongated members contact the ultrasound transducer and allow the ultrasound transducer to slide along the track between the two base components of the one or more base component (Figs. 1A, 1B, and 8, and [0043] “The operative association of carriage translation actuator 62 and carriage 50 includes coupling of actuator shaft 78 to follower shaft 84 to, in response to a rotational force applied to actuator shaft 78, rotate them in opposite directions and thereby move carriage 50 in either direction along the lengths of gear racks 72 and 76 to adjust the position of a medical probe over the surface of a patient’s skin on which base 12 has been set and secured in place.”).
Regarding Claim 9, the modified system of Hansen teaches all limitations of Claim 1, as discussed above. Furthermore, Hansen teaches wherein the one or more securing component is physically integrated with a probe sheath, ([0039] “medical probe holder 60” and Fig. 1A), or a drape.
Regarding Claim 10, the modified system of Hansen teaches all limitations of Claim 9, as discussed above. Furthermore, Hansen teaches wherein the probe sheath or the drape completely or partially cover the ultrasound transducer to substantially maintain a sterile field (Figs. 1A and 1B and [0056] “guide structure 10 is made of medical grade materials to facilitate sterilization of guide structure 10 prior to use.”).
Regarding Claim 17, the modified system of Hansen teaches all limitations of Claim 1, as discussed above. Furthermore, Cermak teaches wherein the one or more securing component provides an aperture, an opening, or a slot, configured to receive the needle, the probe, or the injectable device, wherein the aperture, the opening, or the slot, substantially aligns or guides a percutaneous injection of the needle, the probe, or the injectable device ([0064] “reusable needle guide device 20” and [0089] “any existing prior art imaging transducer can be readily retrofit by means of the adaptor 200 to accommodate the needle guide device 20 (or any other needle guide device making use of the lockable mounting member).”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the teachings of Cermak for the same reasons as Claim 1 above.
Regarding Claim 19, the modified system of Hansen teaches all limitations of Claim 1, as discussed above. Furthermore, Hansen teaches a cable connected to the ultrasound transducer, wherein the cable is oriented relative to one or more of the ultrasound transducer and the one or more base component, to at least one of minimize a vertical profile of the ultrasound transducer relative to the patient contact surface or the target patient anatomy, stabilize one or more of the ultrasound transducer and the one or more base component, and maximize procedure access around a base of the ultrasound transducer (Fig. 8, which shows the cable on the medical probe 61 minimizing a vertical profile of the ultrasound transducer relative to the patient contact surface or the target patient anatomy, stabilizing one or more of the ultrasound transducer and the one or more base component, and maximizing procedure access around a base of the ultrasound transducer).
Claims 7, 11, 25, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen et al. (WO 2021236348) in view of Cermak (US 20160128719), as applied to Claim 1, further in view of Zijlstra (US 20220039829).
Regarding Claim 7, the modified system of Hansen teaches all limitations of Claim 1, as discussed above. However, the modified system of Hansen does not explicitly teach wherein the one or more securing component comprises an acoustically transmissive member between (a) the ultrasound transducer or a probe sheath and (b) the patient contact surface.
In an analogous vascoscope field of endeavor, Zijlstra teaches a system for affixing an ultrasound transducer to a patient, (Claim 1 “A device for assisting entry of a needle comprising a probe comprising at least one array of n*m ultrasound electro-acoustical elements” and Figs. 1a-d, 3a), wherein the one or more securing component comprises an acoustically transmissive member between (a) the ultrasound transducer or a probe sheath and (b) the patient contact surface (Fig. 1b, [0023] “array of electro-acoustical elements 11 may be adapted to form an ultrasound image under an angle of 40-90° relative to the bottom plane of the probe. Therewith the probe can form an ultrasound image of tissue directly in front of the probe or probe holder,” and [0115] “an array of transducers 11, a bottom of the probe 12 located lower than a bottom 22 of the probe holder (indicated with arrows).” Where in order to form an ultrasound image, there must be an acoustically transmissive member between the ultrasound transducer (array of transducers 11) and the patient wearing the device 1.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Zijlstra in order to provide quality ultrasound images.
Regarding Claim 11, the modified system of Hansen teaches all limitations of Claim 1, as discussed above. Furthermore, Zijlstra teaches wherein the one or more securing component comprises an acoustically transmissive component between the ultrasound transducer and a probe sheath or a drape (Fig. 1b, [0023] “array of electro-acoustical elements 11 may be adapted to form an ultrasound image under an angle of 40-90° relative to the bottom plane of the probe. Therewith the probe can form an ultrasound image of tissue directly in front of the probe or probe holder,” and [0115] “an array of transducers 11, a bottom of the probe 12 located lower than a bottom 22 of the probe holder (indicated with arrows).” Where in order to form an ultrasound image, there must be an acoustically transmissive member between the ultrasound transducer (array of transducers 11) and the patient wearing the device 1.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Zijlstra in order to provide quality ultrasound images.
Regarding Claim 25, the modified system of Hansen teaches all limitations of Claim 1, as discussed above. Furthermore, Zijlstra teaches wherein the ultrasound transducer is an ultrasound-based imaging dual-array probe comprising two ultrasound transducer arrays ([0048] “the array of electro-acoustical elements 11 may comprise n*m electro-acoustical elements, wherein n∈[1,10] and m∈[2,210], and optionally at least one second array of electro-acoustical elements located under an angle of 45-90° with respect to the at least one first array of electro-acoustical elements, such as in the form of a (combined) T or X” and [0051] “the present device may comprise at least one array of first electro-acoustical elements, and/or may comprise at least one array of second electro-acoustical elements.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Zijlstra because the modification of a dual-array ultrasound probe reduces interference, provides real-time imaging, and has quality resolution, which are advantages in the insertion procedure and tracking the inserted devices within the patient.
Regarding Claim 27, the modified system of Hansen teaches all limitations of Claim 1, as discussed above. Furthermore, Zijlstra teaches wherein an orientation of the ultrasound transducer and two-dimensional ultrasound image data is processed by a computer processor to form a volumetric three-dimensional ultrasound dataset to formulate a visualization of the target patient anatomy ([0042] “the probe may form 3D images” and Claim 2 “wherein at least one array of electro-acoustical elements is adapted to form an ultrasound image under an angle of 40-90° relative to the bottom plane of the probe”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Zijlstra because the modification enhances the quality of the procedure by providing an output to a user, thereby minimizing risk of error.
Regarding Claim 28, the modified system of Hansen teaches all limitations of Claim 27, as discussed above. Furthermore, Zijlstra teaches wherein the orientation of the ultrasound transducer is used by the computer processor to relate a location of a two-dimensional ultrasound scan plane to the user relative to an anatomical reference comprised of at least one of a ultrasound dataset or a reference model of the target patient anatomy ([0138] “With reference to FIG. 3c. 1: The shunt and skin are inspected. Then a tourniquet is applied. As a preparation ultrasound gel is applied to the probe. And for imaging video glasses are placed on the caretaker's head. 2: The probe with holder is placed on the arm. Then the shunt-traject is inspected using the ultrasound image formed by the probe. The best place for first shunt access is then selected. 3,4: The probe is fixed to the arm and on the specified place by connecting the tourniquet-system band and pulling the band slightly. This enables proper fixation and prevents indentation of the shunt. 5,6: The needle is pushed through the skin and underlying tissue into the shunt, guided by the ultrasound image” and Claim 2 “wherein at least one array of electro-acoustical elements is adapted to form an ultrasound image under an angle of 40-90° relative to the bottom plane of the probe”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Zijlstra for the same reasons as Claim 27 above.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hansen et al. (WO 2021236348) in view of Cermak (US 20160128719) and Zijlstra (US 20220039829), as applied to Claim 1, further in view of Orr et al. (US 5394877).
Regarding Claim 8, the modified system of Hansen teaches all limitations of Claim 7, as discussed above. However, the modified system of Hansen does not explicitly teach wherein the acoustically transmissive member is comprised of an adhesive film that temporarily adheres the ultrasound transducer or the probe sheath to the patient contact surface for the purpose of gel- free scanning.
In an analogous self-adherent ultrasound device field of endeavor, Orr teaches a system for affixing an ultrasound transducer to a patient, (Column 5 Lines 23-24 “a simplified ultrasound device 12 shown positioned against the patient's skin.”), wherein the acoustically transmissive member is comprised of an adhesive film, (Column 5 Line 60 “hydrogel film 26”), that temporarily adheres the ultrasound transducer or the probe sheath to the patient contact surface, (Figs. 2-3), for the purpose of gel-free scanning (No gel is required with the use of the hydrogel film 26.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Orr because the modification requires minimal clean up, as required with the use of a gel, thereby expediting the imaging procedure on the patient.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen et al. (WO 2021236348) in view of Cermak (US 20160128719), as applied to Claim 1, further in view of Desai et al. (US 20220160330).
Regarding Claim 12, the modified system of Hansen teaches all limitations of Claim 1, as discussed above. However, the modified system of Hansen does not explicitly teach wherein the one or more securing component comprises an acoustic coupling dispensation component.
In an analogous wetting in ultrasound imaging procedures field of endeavor, X teaches a system, (Figs. 1-2), wherein the one or more securing component comprises an acoustic coupling dispensation component ([0089] “an ultrashield 10 having an accelerator membrane 100 surrounding the couplant layer 32, wherein the ultrashield 10 is shown attached to a probe 14”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Desai because the modification minimizes cleanup following the imaging procedure, which decreases the amount of time the patient is required to sit for the procedure. Furthermore, the modification eliminates the need for the imaging operator to consistently reapply the acoustic coupling material during the procedure.
Regarding Claim 13, the modified system of Hansen teaches all limitations of Claim 12, as discussed above. Furthermore, Desai teaches wherein the acoustic coupling dispensation component comprises an absorptive pad or a sponge, and wherein the acoustic coupling dispensation component dispenses acoustic coupling fluid to substantially maintain acoustic contact between the ultrasound transducer and one or more of the patient, the patient contact surface, or the target patient anatomy (Fig. 2 and [0085] “the accelerator membrane 100 is moisture absorbent” and [0093] “Since the accelerator membrane 100 is comprised of a compressible material, when pressure is applied during imaging, the accelerator membrane 100 will dispense couplant liquid, such as water, and will reduce in thickness, optionally becoming thinner than the couplant layer 32. The dispensed fluid will be absorbed by the couplant layer 32 which enhances the imaging properties of the couplant layer 32.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the teachings of Desai for the same reasons as Claim 12, as discussed above.
Regarding Claim 14, the modified system of Hansen teaches all limitations of Claim 12, as discussed above. Furthermore, Desai teaches wherein the acoustic coupling dispensation component is completely or partially saturated with water, ([0093] “the accelerator membrane 100 will dispense couplant liquid, such as water”), saline, betadine, or acoustic gel ([0083] “couplant layer 32 comprises a hydrogel”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify with the teachings of Desai because the substances have low attenuation coefficients, as taught by Desai in [0055].
Claims 18 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen et al. (WO 2021236348) in view of Cermak (US 20160128719), as applied to Claim 1, further in view of DeSilets et al. (US 20180303693).
Regarding Claim 18, the modified system of Hansen teaches all limitations of Claim 1, as discussed above. However, the modified system of Hansen does not explicitly teach wherein the one or more base component further comprises or is attached to a drape for covering all or a portion of a patient's body nearby or adjacent to a location where the needle, the probe, or the injectable device is to be inserted into the patient.
In an analogous patient positioning field of endeavor, DeSilets teaches a system, (Abstract “A system for positioning a patient before, during or after a medical procedure”), for affixing an ultrasound transducer to a patient, ([0131] “ultrasound probes,” where one of ordinary skill in the art would understand that an ultrasound probe comprises an ultrasound transducer), wherein the one or more base component further comprises or is attached to a drape for covering all or a portion of a patient's body nearby or adjacent to a location where the needle, the probe, or the injectable device is to be inserted into the patient ([0131] “The fastener components 2105A-D hold the objects in place, including objects that may pass through the surgical opening 2104. The objects may include surgical instruments or surgical tools that are required for a surgical procedure. These surgical instruments or surgical tools may include, for example, including but not limited to, […] mechanical devices like […] ultrasound probes. The fastener components 2105A-D may secure portions of those objects,” where the portion for needle insertion is taught by Zijlstra.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of DeSilets because proper positioning of a patient prior to any medical procedure can be important, as taught by DeSilets in [0002], and the modification ensures sterilization of the treatment site while maintaining proper positioning of the patient.
Regarding Claim 32, the modified system of Hansen teaches all limitations of Claim 1, as discussed above. Furthermore, DeSilets teaches wherein the one or more base component comprises or is integrated into a procedural drape ([0131] “The fastener components 2105A-D hold the objects in place, including objects that may pass through the surgical opening 2104. The objects may include surgical instruments or surgical tools that are required for a surgical procedure. These surgical instruments or surgical tools may include, for example, including but not limited to, […] mechanical devices like […] ultrasound probes. The fastener components 2105A-D may secure portions of those objects”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of DeSilets because proper positioning of a patient prior to any medical procedure can be important, as taught by DeSilets in [0002], and the modification ensures sterilization of the treatment site while maintaining proper positioning of the patient.
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen et al. (WO 2021236348) in view of Cermak (US 20160128719), as applied to Claim 1, further in view of Geelen et al. (US 20200015780).
Regarding Claim 23, the modified system of Hansen teaches all limitations of Claim 1, as discussed above. However, the modified system of Hansen does not explicitly teach one or more sensor for measuring an absolute or a relative orientation of the ultrasound transducer relative to at least one of the one or more base component, the one or more securing component, the patient contact surface, or the patient anatomy.
In an analogous ultrasound probe arrangement field of endeavor, Geelen teaches a system for affixing an ultrasound transducer to a patient, (Abstract “An ultrasound probe is carried by the probe carrier and makes contact with the surface, e.g. skin. This arrangement enables the probe to be held in a desired orientation so that a clinician can work hands-free.”), comprising one or more sensor for measuring an absolute or a relative orientation of the ultrasound transducer relative to at least one of the one or more base component, the one or more securing component, the patient contact surface, or the patient anatomy ([0084] “a position sensor arrangement for sensing the relative position between the holder 18 and the housing 14. The positioning system is used to track the orientation angles of the ultrasound probe.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Geelen because when the probe is stationary for long periods of time, a sensor is able to detect in real-time if the probe has unintentionally moved, disrupting the procedure, as taught by Geelen in [0120].
Regarding Claim 24, the modified system of Hansen teaches all limitations of Claim 23, as discussed above. Furthermore, Geelen teaches wherein at least one of the one or more sensor is disposed within a housing of the ultrasound transducer, ([0122] “One orientation sensor may be attached to the housing”), and wherein at least one of the one or more sensor is disposed within at least one of the one or more base component or the one or more securing component ([0122] “One orientation sensor may be attached to the housing, and a second to the probe carrier.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Geelen for the same reasons as Claim 23, as discussed above.
Claims 26 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen et al. (WO 2021236348) in view of Cermak (US 20160128719), as applied to Claim 1, further in view of McGrath et al. (US 20210228186)
Regarding Claim 26, the modified system of Hansen teaches all limitations of Claim 1, as discussed above. However, modified system of Hansen does not explicitly teach wherein the ultrasound transducer is an ultrasound-based imaging dual-array probe comprising two ultrasound transducer arrays and a longitudinal slot, the two ultrasound transducer arrays disposed on opposing sides of the longitudinal slot.
In an analogous medical imaging using multiple arrays field of endeavor, McGrath teaches a system for affixing an ultrasound transducer to a patient, ([0172] “a device 10 of the present disclosure includes generally three components—a housing 100, a base 200, and an inserter assembly 300” and [0173] “The base 200 provides for positioning and securing the device adjacent to the skin surface of a patient.”), wherein the ultrasound transducer is an ultrasound-based imaging dual-array probe comprising two ultrasound transducer arrays, (Fig. 50), and a longitudinal slot, ([0294] “slot 1510’”), the two ultrasound transducer arrays disposed on opposing sides of the longitudinal slot (Fig. 50).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of McGrath because the modification allows for surgical procedures (or needle insertion) while the transducer array is placed on the target body zone, as taught by McGrath in [0294].
Regarding Claim 29, the modified system of Hansen teaches all limitations of Claim 1, as discussed above. Furthermore, McGrath teaches wherein the ultrasound transducer is an ultrasound-based imaging dual-array probe with dual-arrays, (Fig. 50), disposed on opposing sides of a longitudinal slot, ([0294] “slot 1510’” and Fig. 50), and wherein the longitudinal slot and imaging generated by the dual-arrays provide in-plane guidance for insertion of the needle, the probe, or the injectable device, into an insertion cavity of the patient ([0009] “The present disclosure generally relates generally to visualization techniques associated with devices used in medical procedures. In particular, the present disclosure relates to such devices that can perform a variety of functions including, for example, locating potential intravenous puncture sites on the patient, navigating and manipulating a needle or cannula to the located puncture site (which may include fine-tuning or auto-correction of the position and/or trajectory of a manually or semi-manually inserted needle or cannula through target and/or needle stabilization), and moving the needle or cannula into and through the puncture site to a desired location within a circulatory system of the patient.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of McGrath because the modification allows for surgical procedures (or needle insertion) while the transducer array is placed on the target body zone, as taught by McGrath in [0294].
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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