DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is in response to the communications filed on 04/13/2026, concerning Application No. 17/894,460. The amendments to the claims filed on 04/13/2026 are acknowledged. Presently, claims 1-5 and 7-19 remain pending.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 04/15/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 4, the limitation “the system module” should be changed to “the ultrasound system module”.
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 5, 7, 9, 11, 13-14, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US Patent No. 5,758,650 A, of record, with date of patent 06/02/1998, hereinafter Miller) in view of Halmann et al. (US 2015/0209003 A1, of record, with publication date 07/30/2015, hereinafter Halmann), and further in view of Long, Jr. et al. (US 2017/0196591 A1, with publication date 07/13/2017, hereinafter Long).
Regarding independent claim 1 and similarly independent claim 18, Miller discloses a medical ultrasound system (see, e.g., Fig. 1 with the corresponding disclosure), comprising:
an ultrasound probe (Fig. 1: ultrasound transducer probe 100) coupled with an ultrasound system module (see, e.g., Fig. 1, and Col. 3, lines 5-13, “In FIG. 1, an ultrasound transducer probe 100 is shown in place against the body 102 of a patient. As in known systems, the probe is connected by a cable to various conventional driving, processing and display circuits (not shown) that generate transmission and driving signals for the piezoelectric array (also not shown) in the probe. The array thereby generates an ultrasonic beam (illustrated in FIG. 1 as scan lines 106) that is focused into an interrogation region 108, that is, a region of interest in the patient's body”);
a first console disposed within at least one of the ultrasound probe (100) or the system module, the first console configured to govern operations of the ultrasound probe (100) (see, e.g., Col. 3, lines 5-20, “In FIG. 1, an ultrasound transducer probe 100 is shown in place against the body 102 of a patient. As in known systems, the probe is connected by a cable to various conventional driving, processing and display circuits (not shown) that generate transmission and driving signals for the piezoelectric array (also not shown) in the probe. The array thereby generates an ultrasonic beam (illustrated in FIG. 1 as scan lines 106) that is focused into an interrogation region 108, that is, a region of interest in the patient's body. The acoustic echo signals from the region 108 return to the array and are converted back into electrical signals, which are processed in any known manner to generate a visual representation of the region on a display. The general arrangement of an ultrasonic imaging system, as well as its methods of operation, are well known and are therefore not described further”);
a medical procedural barrier covering the ultrasound probe (100) (see, e.g., Col. 5, lines 10-25, “This preferred mounting arrangement is particularly advantageous in the common case in which the needle guide and needle are in the sterile field of the surgical procedure, but the ultrasound probe itself is not. In these cases, the ultrasound probe is typically covered by a sterile sheath, which is typically made of Latex or of some other flexible synthetic material. The needle guide is then mounted over the sheath”);
an accessory interface apparatus (Fig. 1: needle guide 112, cable 104, console/processing circuits) configured to facilitate operational coupling between the ultrasound probe (100) and one or more optional accessories (Fig. 1: needle 110) (see, e.g., Fig. 1, and Col. 3, lines 5-13, “In FIG. 1, an ultrasound transducer probe 100 is shown in place against the body 102 of a patient. As in known systems, the probe is connected by a cable to various conventional driving, processing and display circuits (not shown) that generate transmission and driving signals for the piezoelectric array (also not shown) in the probe. The array thereby generates an ultrasonic beam (illustrated in FIG. 1 as scan lines 106) that is focused into an interrogation region 108, that is, a region of interest in the patient's body”, and Col. 3, lines 35-40, “The needle 110 is guided and secured by a needle guide, which is indicated generally as the guide 112. The main features of the guide 112 are a main guide body 114, a removable, exchangeable needle cap 116 that fits and is held onto the main body, and a mounting arrangement 118, which is attached to or is an integral portion of the main body 114”, and Col. 3, lines 53-57, “The mounting arrangement 118 preferably includes, for example, arms with protrusions (FIG. 2) that fit into respective indentations, recesses or grooves on either side of the probe 100, as well as in a side surface 130 of the probe, to fix the position of the needle guide relative to the probe”), the accessory interface apparatus (Fig. 1: needle guide 112, cable 104, console/processing circuits) including:
a housing (Fig. 1: main guide body 114 of needle guide 112 and comprising mounting arrangement 118) attached to the ultrasound probe (100) across the medical procedure barrier (see, e.g., Col. 5, lines 10-25, “This preferred mounting arrangement is particularly advantageous in the common case in which the needle guide and needle are in the sterile field of the surgical procedure, but the ultrasound probe itself is not. In these cases, the ultrasound probe is typically covered by a sterile sheath, which is typically made of Latex or of some other flexible synthetic material. The needle guide is then mounted over the sheath. Using know[n] needle guide mounts, there is a tendency to subject the sheath to rolling and shearing stresses where the guide contacts the sheath. These stresses frequently lead to puncturing of the sheath, and resulting violation of the sterile field. The mounting arrangement according to the invention allows for gentler, controlled, non-torquing and non-shearing mounting of the guide onto the probe and thus greatly reduces the risk of puncturing the sheath”, where the claimed accessory interface apparatus includes the disclosed needle guide mounting arrangement 112, which is coupled to the ultrasound probe 100 across/over the sterile sheath); and
a probe interface configured to facilitate data exchange between the ultrasound probe (100) and the accessory interface apparatus (Fig. 1: needle guide 112, cable 104, console/processing circuits) (see, e.g., Fig. 1, and Col. 3, lines 5-13, “In FIG. 1, an ultrasound transducer probe 100 is shown in place against the body 102 of a patient. As in known systems, the probe is connected by a cable to various conventional driving, processing and display circuits (not shown) that generate transmission and driving signals for the piezoelectric array (also not shown) in the probe. The array thereby generates an ultrasonic beam (illustrated in FIG. 1 as scan lines 106) that is focused into an interrogation region 108, that is, a region of interest in the patient's body”, and Col. 3, lines 35-40, “The needle 110 is guided and secured by a needle guide, which is indicated generally as the guide 112. The main features of the guide 112 are a main guide body 114, a removable, exchangeable needle cap 116 that fits and is held onto the main body, and a mounting arrangement 118, which is attached to or is an integral portion of the main body 114”, and Col. 3, lines 53-57, “The mounting arrangement 118 preferably includes, for example, arms with protrusions (FIG. 2) that fit into respective indentations, recesses or grooves on either side of the probe 100, as well as in a side surface 130 of the probe, to fix the position of the needle guide relative to the probe”) across the medical procedural barrier (see, e.g., Col. 5, lines 10-25, “This preferred mounting arrangement is particularly advantageous in the common case in which the needle guide and needle are in the sterile field of the surgical procedure, but the ultrasound probe itself is not. In these cases, the ultrasound probe is typically covered by a sterile sheath, which is typically made of Latex or of some other flexible synthetic material. The needle guide is then mounted over the sheath. Using know[n] needle guide mounts, there is a tendency to subject the sheath to rolling and shearing stresses where the guide contacts the sheath. These stresses frequently lead to puncturing of the sheath, and resulting violation of the sterile field. The mounting arrangement according to the invention allows for gentler, controlled, non-torquing and non-shearing mounting of the guide onto the probe and thus greatly reduces the risk of puncturing the sheath”, where the claimed accessory interface apparatus includes the disclosed needle guide mounting arrangement 112, which is coupled to the ultrasound probe 100 across/over the sterile sheath),
wherein one or more processors and a non-transitory computer-readable storage medium having logic stored thereon that when executed by the one or more processors performs operations of the accessory interface apparatus (Fig. 1: needle guide 112, cable 104, console/processing circuits) (see, e.g., Col. 3, lines 6-9, “As in known systems, the probe is connected by a cable to various conventional driving, processing and display circuits (not shown)”) that include:
exchanging data across the medical procedural barrier between the accessory interface apparatus (Fig. 1: needle guide 112, cable 104, console/processing circuits) and the ultrasound probe (100) via the probe interface (see, e.g., Col. 3, lines 5-10, “In FIG. 1, an ultrasound transducer probe 100 is shown in place against the body 102 of a patient. As in known systems, the probe is connected by a cable to various conventional driving, processing and display circuits (not shown) that generate transmission and driving signals for the piezoelectric array (also not shown) in the probe”, and Col. 5, lines 10-25, “This preferred mounting arrangement is particularly advantageous in the common case in which the needle guide and needle are in the sterile field of the surgical procedure, but the ultrasound probe itself is not. In these cases, the ultrasound probe is typically covered by a sterile sheath, which is typically made of Latex or of some other flexible synthetic material. The needle guide is then mounted over the sheath. Using know[n] needle guide mounts, there is a tendency to subject the sheath to rolling and shearing stresses where the guide contacts the sheath. These stresses frequently lead to puncturing of the sheath, and resulting violation of the sterile field. The mounting arrangement according to the invention allows for gentler, controlled, non-torquing and non-shearing mounting of the guide onto the probe and thus greatly reduces the risk of puncturing the sheath”).
Miller does not specifically disclose [1] the accessory interface apparatus including: a second console configured to govern operations of the accessory interface apparatus, the second console disposed within the housing; [2] wherein the second console includes one or more processors and a non-transitory computer-readable storage medium having logic stored thereon that when executed by the one or more processors performs operations of the accessory interface apparatus; and [3] receiving input from the one or more optional accessories via an input/output (I/O) portal of the accessory interface apparatus.
However, in the same field of endeavor of ultrasound probes, Halmann discloses receiving input from the one or more optional accessories (needle 30) via an input/output (I/O) portal of the accessory interface apparatus (needle tracking system 40, cables 60, console 70) (see, e.g., Para. [0011-0012], and Para. [0013], “In one embodiment needle tracking system 40 may rely upon signals obtained from the needle 30. The needle 30 or a portion thereof may be magnetized and needle tracking system 40 may rely on magnetic interactions with the needle 30. The needle 30 may be provided with a radio frequency identification (RFID) tag and the tag may be probed by the needle tracking system 40. The needle tracking system 40 may rely upon any of the known optical, mechanical, magnetic or electro-magnetic tracking technologies that provides a reasonable estimate of the location of a needle 30 inserted into living tissue 20”), and
exchanging data between the accessory interface apparatus (40, 60, 70) and the ultrasound probe (10) (see, e.g., Para. [0011-0014], where data is exchanged between the accessory interface apparatus (corresponding to 40, 60, 70) and the ultrasound probe (corresponding to 10) in order to provide a display image comprising the ultrasound image 82 obtained from the probe 10 and also comprising the graphical overlay 80 that indicates the predicted needle location data based on the signals received from the needle 30 obtained from the accessory interface apparatus (corresponding to 40, 60, 70)).
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 medical ultrasound system and the accessory interface apparatus of Miller by including [3] receiving input from the one or more optional accessories via an input/output (I/O) portal of the accessory interface apparatus, as disclosed by Halmann. One of ordinary skill in the art would have been motivated to make this modification in order to provides a reasonable estimate of the location of a needle inserted into living tissue, as recognized by Halmann (see, e.g., Para. [0013]).
Miller modified by Halmann does not specifically disclose [1] the accessory interface apparatus including: a second console configured to govern operations of the accessory interface apparatus, the second console disposed within the housing; [2] wherein the second console includes one or more processors and a non-transitory computer-readable storage medium having logic stored thereon that when executed by the one or more processors performs operations of the accessory interface apparatus.
However, in the same field of endeavor of ultrasound probes, Long discloses the accessory interface apparatus including: a second console configured to govern operations of the accessory interface apparatus, the second console disposed within the housing, wherein the second console includes one or more processors and a non-transitory computer-readable storage medium having logic stored thereon that when executed by the one or more processors performs operations of the accessory interface apparatus (see, e.g., Para. [0049], “Processor 40 is described as a separate element, but may integral with pad 10. For example, processor 40 may be housed inside of pad 110. As noted above, any aspect of processor 40 may be used to receive motion signals from sensors 12A-C and track, via triangulation, the disposition of needle 20. Any number of sensors may be used. Thus, processor 40 may be configured to utilize the additional motion signals within any location determining algorithm” (emphasis added)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the medical ultrasound system and the accessory interface apparatus of Miller modified by Halmann by including [1] the accessory interface apparatus including: a second console configured to govern operations of the accessory interface apparatus, the second console disposed within the housing; [2] wherein the second console includes one or more processors and a non-transitory computer-readable storage medium having logic stored thereon that when executed by the one or more processors performs operations of the accessory interface apparatus, as disclosed by Long. One of ordinary skill in the art would have been motivated to make this modification in order to desirably track the disposition of the needle/accessory, as recognized by Long (see, e.g., Para. [0049]).
Regarding claim 2, Miller modified by Halmann and Long discloses the medical ultrasound system of claim 1, as set forth above. Miller further discloses the medical ultrasound system further comprising a display coupled with the ultrasound probe (see, e.g., Col. 3, lines 5-17, “In FIG. 1, an ultrasound transducer probe 100 is shown in place against the body 102 of a patient. As in known systems, the probe is connected by a cable to various conventional driving, processing and display circuits (not shown) that generate transmission and driving signals for the piezoelectric array (also not shown) in the probe. The array thereby generates an ultrasonic beam (illustrated in FIG. 1 as scan lines 106) that is focused into an interrogation region 108, that is, a region of interest in the patient's body. The acoustic echo signals from the region 108 return to the array and are converted back into electrical signals, which are processed in any known manner to generate a visual representation of the region on a display”).
Miller does not specifically disclose the operations further including depicting information on the display pertaining to the operation of the receiving the input from the one or more optional accessories in combination with an ultrasound image obtained by the ultrasound probe.
However, in the same field of endeavor of ultrasound probes, Halmann discloses the medical ultrasound system further comprising a display (display 72) coupled with the ultrasound probe (ultrasound probe head 10) (see, e.g., Para. [0011]), the operations further including depicting information on the display (72) pertaining to the operation of the receiving the input from the one or more optional accessories (needle 30) in combination with an ultrasound image obtained by the ultrasound probe (see, e.g., Para. [0011], “The console 70 has a processor for receiving and manipulating signals received from both the probe head 10 and the needle tracking system 40. The console 70 also has a display 72 on which the ultrasound image obtained from the probe head 10 may be viewed. The display may provide a graphical overlay 80 of the hollow needle 30 generated from information provided by the needle tracking system 40”, and Para. [0012-0013], and Para. [0014], “Referring to FIG. 2, the display 72 provides an ultrasound image 82 of the tissue 20 on which a predicted location 80 of needle 30 has been identified. The predicted location 80 of needle 30 is generated from data supplied by the needle tracking system 40. It provides approximate information as to the location of the needle 30 in the tissue 20. However, the graphical overlay 80 is not obtained from the ultrasound data used to image the tissue 20. Thus it does not represent an ultrasound image of the needle 30”, where data is exchanged between the accessory interface apparatus (corresponding to 40, 60, 70) and the ultrasound probe (corresponding to 10) in order to provide a display image comprising the ultrasound image 82 obtained from the probe 10 and also comprising the graphical overlay 80 that indicates the predicted needle location data based on the signals received from the needle 30 obtained from the accessory interface apparatus (corresponding to 40, 60, 70)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the medical ultrasound system of Miller modified by Halmann and Long by including the operations further including depicting information on the display pertaining to the operation of the receiving the input from the one or more optional accessories in combination with an ultrasound image obtained by the ultrasound probe, as disclosed by Halmann. One of ordinary skill in the art would have been motivated to make this modification in order to provides a reasonable estimate of the location of a needle inserted into living tissue, as recognized by Halmann (see, e.g., Para. [0013]).
Regarding claim 5, Miller modified by Halmann and Long discloses the medical ultrasound system of claim 1, as set forth above. Miller further discloses wherein the accessory interface apparatus is configured to selectively attach to and detach from the ultrasound probe (see, e.g., Col. 5, lines 10-25, “This preferred mounting arrangement is particularly advantageous in the common case in which the needle guide and needle are in the sterile field of the surgical procedure, but the ultrasound probe itself is not. In these cases, the ultrasound probe is typically covered by a sterile sheath, which is typically made of Latex or of some other flexible synthetic material. The needle guide is then mounted over the sheath. Using know[n] needle guide mounts, there is a tendency to subject the sheath to rolling and shearing stresses where the guide contacts the sheath. These stresses frequently lead to puncturing of the sheath, and resulting violation of the sterile field. The mounting arrangement according to the invention allows for gentler, controlled, non-torquing and non-shearing mounting of the guide onto the probe and thus greatly reduces the risk of puncturing the sheath”, where the claimed accessory interface apparatus includes the disclosed needle guide mounting arrangement, which is coupled to the ultrasound probe across/over the sterile sheath).
Regarding claim 7, Miller modified by Halmann and Long discloses the medical ultrasound system of claim 1, as set forth above. Miller further discloses the medical ultrasound system further comprising the medical procedural barrier, the medical procedural barrier including a sheath covering the ultrasound probe (see, e.g., Col. 5, lines 10-25, “This preferred mounting arrangement is particularly advantageous in the common case in which the needle guide and needle are in the sterile field of the surgical procedure, but the ultrasound probe itself is not. In these cases, the ultrasound probe is typically covered by a sterile sheath, which is typically made of Latex or of some other flexible synthetic material. The needle guide is then mounted over the sheath. Using know[n] needle guide mounts, there is a tendency to subject the sheath to rolling and shearing stresses where the guide contacts the sheath. These stresses frequently lead to puncturing of the sheath, and resulting violation of the sterile field. The mounting arrangement according to the invention allows for gentler, controlled, non-torquing and non-shearing mounting of the guide onto the probe and thus greatly reduces the risk of puncturing the sheath”).
Regarding claim 9, Miller modified by Halmann and Long discloses the medical ultrasound system of claim 1, as set forth above. Miller does not specifically disclose wherein the I/O portal includes one or more of an electrical connection, an optical coupling, an inductive coupling or a wireless connection between the accessory interface apparatus and the one or more optional accessories.
However, in the same field of endeavor of ultrasound probes, Halmann discloses wherein the I/O portal includes one or more of an electrical connection, an optical coupling, an inductive coupling (see, e.g., Para. [0011], “Referring to FIG. 1, an ultrasound probe head 10 is placed adjacent to living tissue 20, such as human tissue. A needle tracking system 40 is attached to the probe head 10 and measures the depth and angle of insertion of a hollow needle 30. […] The probe head 10 is connected to cables 60 which are, in turn, connected to an ultrasound console 70. The console 70 has a processor for receiving and manipulating signals received from both the probe head 10 and the needle tracking system 40”, and Para. [0012], “In one embodiment, the needle tracking system 40 supplies data to the console 70 from which an estimate of the position of the needle 30 is formulated and may be graphically represented a feature 80. In one embodiment, the data from the needle tracking system 40 includes the angle of insertion, the depth of insertion, and the angle of insertion of needle 30 into tissue 20. This data is used to provide a predicted position 80 of needle 30”, and Para. [0013], “In one embodiment needle tracking system 40 may rely upon signals obtained from the needle 30. The needle 30 or a portion thereof may be magnetized and needle tracking system 40 may rely on magnetic interactions with the needle 30. The needle 30 may be provided with a radio frequency identification (RFID) tag and the tag may be probed by the needle tracking system 40. The needle tracking system 40 may rely upon any of the known optical, mechanical, magnetic or electro-magnetic tracking technologies that provides a reasonable estimate of the location of a needle 30 inserted into living tissue 20”) or a wireless connection between the accessory interface apparatus and the one or more optional accessories (see, e.g., Para. [0013], “In one embodiment needle tracking system 40 may rely upon signals obtained from the needle 30. The needle 30 or a portion thereof may be magnetized and needle tracking system 40 may rely on magnetic interactions with the needle 30. The needle 30 may be provided with a radio frequency identification (RFID) tag and the tag may be probed by the needle tracking system 40. The needle tracking system 40 may rely upon any of the known optical, mechanical, magnetic or electro-magnetic tracking technologies that provides a reasonable estimate of the location of a needle 30 inserted into living tissue 20”, where RFID communication is a wireless connection).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the medical ultrasound system of Miller modified by Halmann and Long by including wherein the I/O portal includes one or more of an electrical connection, an optical coupling, an inductive coupling or a wireless connection between the accessory interface apparatus and the one or more optional accessories, as disclosed by Halmann. One of ordinary skill in the art would have been motivated to make this modification in order to provides a reasonable estimate of the location of a needle inserted into living tissue, as recognized by Halmann (see, e.g., Para. [0013]).
Regarding claim 11, Miller modified by Halmann and Long discloses the medical ultrasound system of claim 1, as set forth above. Miller does not specifically disclose the medical ultrasound system further comprising input devices configured to provide the input to the accessory interface apparatus via the I/O portal, wherein the input devices include one or more of: an operator interface including buttons, a joystick, or a scroll wheel; fingerprint scanner; microphone; an IR receiver; an RFID reader; a scanner; and a camera.
However, in the same field of endeavor of ultrasound probes, Halmann discloses the medical ultrasound system further comprising input devices configured to provide the input to the accessory interface apparatus (needle tracking system 40, cables 60, console 70) via the I/O portal, wherein the input devices include one or more of: an operator interface including buttons, a joystick, or a scroll wheel; fingerprint scanner; microphone; an IR receiver; an RFID reader (see, e.g., Para. [0013], “In one embodiment needle tracking system 40 may rely upon signals obtained from the needle 30. The needle 30 or a portion thereof may be magnetized and needle tracking system 40 may rely on magnetic interactions with the needle 30. The needle 30 may be provided with a radio frequency identification (RFID) tag and the tag may be probed by the needle tracking system 40. The needle tracking system 40 may rely upon any of the known optical, mechanical, magnetic or electro-magnetic tracking technologies that provides a reasonable estimate of the location of a needle 30 inserted into living tissue 20”); a scanner; and a camera.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the medical ultrasound system of Miller modified by Halmann and Long by including the medical ultrasound system further comprising input devices configured to provide the input to the accessory interface apparatus via the I/O portal, wherein the input devices include one or more of: an operator interface including buttons, a joystick, or a scroll wheel; fingerprint scanner; microphone; an IR receiver; an RFID reader; a scanner; and a camera, as disclosed by Halmann. One of ordinary skill in the art would have been motivated to make this modification in order to provides a reasonable estimate of the location of a needle inserted into living tissue, as recognized by Halmann (see, e.g., Para. [0013]).
Regarding claim 13, Miller modified by Halmann and Long discloses the medical ultrasound system of claim 1, as set forth above. Miller does not specifically disclose wherein the one or more optional accessories include one or more of: a needle guide connector configured for attachment of a needle guide thereto, a triphalangeal support structure, and an acoustically transparent cap.
However, in the same field of endeavor of ultrasound probes, Halmann discloses wherein the one or more optional accessories (needle 30) include one or more of: a needle guide connector configured for attachment of a needle guide thereto (see, e.g., Para. [0011], “Referring to FIG. 1, […] A needle tracking system 40 is attached to the probe head 10 and measures the depth and angle of insertion of a hollow needle 30”, and Para. [0012], “In one embodiment, the needle tracking system 40 supplies data to the console 70 from which an estimate of the position of the needle 30 is formulated and may be graphically represented a feature 80. In one embodiment, the data from the needle tracking system 40 includes the angle of insertion, the depth of insertion, and the angle of insertion of needle 30 into tissue 20. This data is used to provide a predicted position 80 of needle 30”, and Para. [0013], “In one embodiment needle tracking system 40 may rely upon signals obtained from the needle 30. The needle 30 or a portion thereof may be magnetized and needle tracking system 40 may rely on magnetic interactions with the needle 30. The needle 30 may be provided with a radio frequency identification (RFID) tag and the tag may be probed by the needle tracking system 40. The needle tracking system 40 may rely upon any of the known optical, mechanical, magnetic or electro-magnetic tracking technologies that provides a reasonable estimate of the location of a needle 30 inserted into living tissue 20. In one embodiment the needle tracking system is a non-ultrasound system. In another embodiment the needle tracking system may be an ultrasound system. In one embodiment, the needle tracking system is physically attached to the transceiver of the ultrasound imaging system”), a triphalangeal support structure, and an acoustically transparent cap.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the medical ultrasound system of Miller modified by Halmann and Long by including wherein the one or more optional accessories include one or more of: a needle guide connector configured for attachment of a needle guide thereto, a triphalangeal support structure, and an acoustically transparent cap, as disclosed by Halmann. One of ordinary skill in the art would have been motivated to make this modification in order to provides a reasonable estimate of the location of a needle inserted into living tissue, as recognized by Halmann (see, e.g., Para. [0013]).
Regarding claim 14, Miller modified by Halmann and Long discloses the medical ultrasound system of claim 1, as set forth above. Miller does not specifically disclose wherein: the input includes an RFID signal from at least one of the one or more optional accessories indicating an identification of the at least one of the one or more optional accessories, and the operations further include configuring the accessory interface apparatus to receive and process the input from the at least one of the one or more optional accessories.
However, in the same field of endeavor of ultrasound probes, Halmann discloses wherein: the input includes an RFID signal from at least one of the one or more optional accessories (needle 30) indicating an identification of the at least one of the one or more optional accessories (30), and the operations further include configuring the accessory interface apparatus (needle tracking system 40, cables 60, console 70) to receive and process the input from the at least one of the one or more optional accessories (30) (see, e.g., Para. [0013], “In one embodiment needle tracking system 40 may rely upon signals obtained from the needle 30. The needle 30 or a portion thereof may be magnetized and needle tracking system 40 may rely on magnetic interactions with the needle 30. The needle 30 may be provided with a radio frequency identification (RFID) tag and the tag may be probed by the needle tracking system 40. The needle tracking system 40 may rely upon any of the known optical, mechanical, magnetic or electro-magnetic tracking technologies that provides a reasonable estimate of the location of a needle 30 inserted into living tissue 20. In one embodiment the needle tracking system is a non-ultrasound system. In another embodiment the needle tracking system may be an ultrasound system. In one embodiment, the needle tracking system is physically attached to the transceiver of the ultrasound imaging system”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the medical ultrasound system of Miller modified by Halmann and Long by including wherein: the input includes an RFID signal from at least one of the one or more optional accessories indicating an identification of the at least one of the one or more optional accessories, and the operations further include configuring the accessory interface apparatus to receive and process the input from the at least one of the one or more optional accessories, as disclosed by Halmann. One of ordinary skill in the art would have been motivated to make this modification in order to provides a reasonable estimate of the location of a needle inserted into living tissue, as recognized by Halmann (see, e.g., Para. [0013]).
Regarding claim 16, Miller modified by Halmann and Long discloses the medical ultrasound system of claim 1, as set forth above. Miller does not specifically disclose wherein: the one or more optional accessories include a magnetic tracking system configured to track a location and orientation of a needle, and the input includes data pertaining to the location and the orientation of the needle with respect to the ultrasound probe.
However, in the same field of endeavor of ultrasound probes, Halmann discloses wherein: the one or more optional accessories (needle 30) include a magnetic tracking system configured to track a location and orientation of a needle, and the input includes data pertaining to the location and the orientation of the needle with respect to the ultrasound probe (ultrasound probe head 10) (see, e.g., Para. [0011], “Referring to FIG. 1, an ultrasound probe head 10 is placed adjacent to living tissue 20, such as human tissue. A needle tracking system 40 is attached to the probe head 10 and measures the depth and angle of insertion of a hollow needle 30. […] The probe head 10 is connected to cables 60 which are, in turn, connected to an ultrasound console 70. The console 70 has a processor for receiving and manipulating signals received from both the probe head 10 and the needle tracking system 40”, and Para. [0012], “In one embodiment, the needle tracking system 40 supplies data to the console 70 from which an estimate of the position of the needle 30 is formulated and may be graphically represented a feature 80. In one embodiment, the data from the needle tracking system 40 includes the angle of insertion, the depth of insertion, and the angle of insertion of needle 30 into tissue 20. This data is used to provide a predicted position 80 of needle 30”, and Para. [0013], “In one embodiment needle tracking system 40 may rely upon signals obtained from the needle 30. The needle 30 or a portion thereof may be magnetized and needle tracking system 40 may rely on magnetic interactions with the needle 30. The needle 30 may be provided with a radio frequency identification (RFID) tag and the tag may be probed by the needle tracking system 40. The needle tracking system 40 may rely upon any of the known optical, mechanical, magnetic or electro-magnetic tracking technologies that provides a reasonable estimate of the location of a needle 30 inserted into living tissue 20. In one embodiment the needle tracking system is a non-ultrasound system. In another embodiment the needle tracking system may be an ultrasound system. In one embodiment, the needle tracking system is physically attached to the transceiver of the ultrasound imaging system”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the medical ultrasound system of Miller modified by Halmann and Long by including wherein: the one or more optional accessories include a magnetic tracking system configured to track a location and orientation of a needle, and the input includes data pertaining to the location and the orientation of the needle with respect to the ultrasound probe, as disclosed by Halmann. One of ordinary skill in the art would have been motivated to make this modification in order to provides a reasonable estimate of the location of a needle inserted into living tissue, as recognized by Halmann (see, e.g., Para. [0013]).
Claims 3 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (US Patent No. 5,758,650 A) in view of Halmann (US 2015/0209003 A1) and Long (US 2017/0196591 A1), as applied to claims 1-2 above, and further in view of Messerly (US 2018/0289927 A1, of record, hereinafter Messerly).
Regarding claim 3, Miller modified by Halmann and Long discloses the medical ultrasound system of claim 2, as set forth above. Miller modified by Halmann and Long does not disclose wherein: the one or more optional accessories include a blood vessel identification system; the input includes image data related to an identification and a location of at least one blood vessel beneath skin of a patient; and the operations further include portraying an image of the at least one blood vessel on the display in combination with the ultrasound image.
However, in the same field of endeavor of medical ultrasound systems, Messerly discloses wherein: the one or more optional accessories include a blood vessel identification system; the input includes image data related to an identification and a location of at least one blood vessel beneath skin of a patient; and the operations further include portraying an image of the at least one blood vessel on the display in combination with the ultrasound image (see, e.g., Para. [0030], “The probe 40 is employed in connection with the first modality mentioned above, i.e., ultrasound (“US”)-based visualization of a vessel, such as a vein, in preparation for insertion of the catheter 72 into the vasculature. Such visualization gives real time ultrasound guidance for introducing the catheter into the vasculature of the patient and assists in reducing complications typically associated with such introduction, including inadvertent arterial puncture, hematoma, pneumothorax, etc.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the medical ultrasound system of Miller modified by Halmann and Long by including wherein: the one or more optional accessories include a blood vessel identification system; the input includes image data related to an identification and a location of at least one blood vessel beneath skin of a patient; and the operations further include portraying an image of the at least one blood vessel on the display in combination with the ultrasound image, as disclosed by Messerly. One of ordinary skill in the art would have been motivated to make this modification in order to provide such visualization that gives real time ultrasound guidance for introducing the catheter into the vasculature of the patient and assists in reducing complications typically associated with such introduction, as recognized by Messerly (see, e.g., Para. [0030]).
Regarding claim 15, Miller modified by Halmann and Long discloses the medical ultrasound system of claim 1, as set forth above. Miller modified by Halmann and Long does not disclose wherein: the one or more optional accessories include an elongate probe including an optical fiber having a number of sensors disposed along a length of the optical fiber, the input includes optical signals, and the operations further include processing the optical signals to determine one or more of: fluid or tissue motion adjacent the optical fiber; an image acquired by the optical fiber; a shape or strain of the optical fiber; and a motion of the optical fiber .
However, in the same field of endeavor of medical ultrasound systems, Messerly discloses wherein: the one or more optional accessories include an elongate probe including an optical fiber having a number of sensors disposed along a length of the optical fiber, the input includes optical signals, and the operations further include processing the optical signals to determine one or more of: fluid or tissue motion adjacent the optical fiber; an image acquired by the optical fiber; a shape or strain of the optical fiber; and a motion of the optical fiber (see, e.g., Para. [0019], “Embodiments of the present invention are generally directed to a placement system for tracking, placing, and monitoring a medical device inserted into a body of a patient. An example of such a medical device is a catheter assembly that is inserted into a vein or other vessel of the patient so as to infuse or aspirate fluids through one or more lumens defined by the catheter for the patient. The system utilizes optical fiber-based strain sensors in one embodiment to ascertain information regarding the catheter or other medical device during and/or after insertion into the patient's body”, and Para. [0020], “the strain sensors include fiber Bragg grating (“FBG”) sensors distributed along an optical fiber disposed in/on the catheter assembly (or other medical device). An outgoing optical signal produced by a swept laser is incident on each of the FBG sensors in the fiber, which each respond, producing a return optical signal. A processor of the placement system processes the return optical signal with predetermined algorithms to determine the strain and other data of each of the FBG sensors. The data is communicated to a user of the system and can provide information regarding the medical device, its position within the body, the 2-D and 3-D shape of the medical device along its length (e.g., bending, torsion), device orientation (including malposition or device kinking), body temperature, fluid level within the medical device, device pressure, stiffness, and operational load, etc.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the medical ultrasound system of Miller modified by Halmann and Long by including wherein: the one or more optional accessories include an elongate probe including an optical fiber having a number of sensors disposed along a length of the optical fiber, the input includes optical signals, and the operations further include processing the optical signals to determine one or more of: fluid or tissue motion adjacent the optical fiber; an image acquired by the optical fiber; a shape or strain of the optical fiber; and a motion of the optical fiber, as disclosed by Messerly. One of ordinary skill in the art would have been motivated to make this modification in order to improve medical device placement accuracy, as recognized by Messerly (see, e.g., Para. [0019-0022]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Miller (US Patent No. 5,758,650 A) in view of Halmann (US 2015/0209003 A1) and Long (US 2017/0196591 A1), as applied to claim 1 above, and further in view of Poland et al. (US 2010/0168576 A1, of record, with publication date 07/01/2010, hereinafter Poland).
Regarding claim 4, Miller modified by Halmann and Long discloses the medical ultrasound system of claim 1, as set forth above. Miller further discloses wherein the probe interface is configured to facilitate data exchange between the ultrasound probe (100) and the accessory interface apparatus (Fig. 1: needle guide 112, cable 104, console/processing circuits) (see, e.g., Fig. 1, and Col. 3, lines 5-13, “In FIG. 1, an ultrasound transducer probe 100 is shown in place against the body 102 of a patient. As in known systems, the probe is connected by a cable to various conventional driving, processing and display circuits (not shown) that generate transmission and driving signals for the piezoelectric array (also not shown) in the probe. The array thereby generates an ultrasonic beam (illustrated in FIG. 1 as scan lines 106) that is focused into an interrogation region 108, that is, a region of interest in the patient's body”, and Col. 3, lines 35-40, “The needle 110 is guided and secured by a needle guide, which is indicated generally as the guide 112. The main features of the guide 112 are a main guide body 114, a removable, exchangeable needle cap 116 that fits and is held onto the main body, and a mounting arrangement 118, which is attached to or is an integral portion of the main body 114”, and Col. 3, lines 53-57, “The mounting arrangement 118 preferably includes, for example, arms with protrusions (FIG. 2) that fit into respective indentations, recesses or grooves on either side of the probe 100, as well as in a side surface 130 of the probe, to fix the position of the needle guide relative to the probe”) across the medical procedural barrier (see, e.g., Col. 5, lines 10-25, “This preferred mounting arrangement is particularly advantageous in the common case in which the needle guide and needle are in the sterile field of the surgical procedure, but the ultrasound probe itself is not. In these cases, the ultrasound probe is typically covered by a sterile sheath, which is typically made of Latex or of some other flexible synthetic material. The needle guide is then mounted over the sheath. Using know[n] needle guide mounts, there is a tendency to subject the sheath to rolling and shearing stresses where the guide contacts the sheath. These stresses frequently lead to puncturing of the sheath, and resulting violation of the sterile field. The mounting arrangement according to the invention allows for gentler, controlled, non-torquing and non-shearing mounting of the guide onto the probe and thus greatly reduces the risk of puncturing the sheath”, where the claimed accessory interface apparatus includes the disclosed needle guide mounting arrangement 112, which is coupled to the ultrasound probe 100 across/over the sterile sheath), as set forth above.
Miller modified by Halmann and Long does not specifically disclose wherein the probe interface is configured to provide electrical power across the medical procedural barrier to the accessory interface from the ultrasound probe via at least one of electrical contacts or a magnetic field configured to inductively transfer the electrical power to the accessory interface apparatus.
However, in the same field of endeavor of ultrasound probes, Poland discloses wherein the probe interface is configured to provide electrical power to the accessory interface from the ultrasound probe via at least one of electrical contacts or a magnetic field configured to inductively transfer the electrical power to the accessory interface apparatus (see, e.g., Para. [0048], “FIG. 10a illustrates a cable suitable for use with a wireless probe of the present invention. While various types of multi-conductor cables and connectors can be used for a wireless probe, this example is a multi-conductor USB cable 300 with a USB type A connector 310 at one end. Extending from the connector 310 is a type A USB adapter 312. Other USB formats may alternatively be employed, such as type B and mini-B as is found on digital cameras, or a completely custom connector with other desirable properties may be employed. A USB cable can be plugged into virtually any desktop or laptop computer, enabling the wireless probe to be charged from virtually any computer. When the host system is a laptop-style ultrasound system 50 as shown in FIGS. 2b and 6a, the USB-type cable can be used for both signal communication to and from the host as well as power”, where the cable can be used to transmit power and signal communication to and from the probe and the interface apparatus/connector, thus the interface apparatus can receive electrical power from the probe via electrical contacts associated with the cable).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the medical ultrasound system of Miller modified by Halmann and Long by including wherein the probe interface is configured to provide electrical power to the accessory interface from the ultrasound probe via at least one of electrical contacts or a magnetic field configured to inductively transfer the electrical power to the accessory interface apparatus, as disclosed by Poland. One of ordinary skill in the art would have been motivated to make this modification in order to improve communication performance, such as a greater bandwidth for transmission of diagnostics or upgrades of the probe's firmware or software, as recognized by Poland (see, e.g., Para. [0047-0048]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Miller (US Patent No. 5,758,650 A) in view of Halmann (US 2015/0209003 A1) and Long (US 2017/0196591 A1), as applied to claim 1 above, and further in view of Halmann et al. (US 2016/0000399 A1, of record, with publication date 01/07/2016, hereinafter Halmann ‘399).
Regarding claim 8, Miller modified by Halmann and Long discloses the medical ultrasound system of claim 1, as set forth above. Halmann further discloses wherein the exchanging the data takes place (see, e.g., Para. [0013], “In one embodiment needle tracking system 40 may rely upon signals obtained from the needle 30. The needle 30 or a portion thereof may be magnetized and needle tracking system 40 may rely on magnetic interactions with the needle 30. The needle 30 may be provided with a radio frequency identification (RFID) tag and the tag may be probed by the needle tracking system 40. The needle tracking system 40 may rely upon any of the known optical, mechanical, magnetic or electro-magnetic tracking technologies that provides a reasonable estimate of the location of a needle 30 inserted into living tissue 20”), as set forth above.
Miller modified by Halmann and Long does not specifically disclose wherein the exchanging the data [between the accessory interface apparatus and the ultrasound probe] takes place across at least one of a wireless connection or an optical connection.
However, in the same field of endeavor of ultrasound needle guidance, Halmann ‘399 discloses wherein the exchanging the data [between the accessory interface apparatus (needle 90, needle tracking system 93) and the ultrasound probe (probe 106, ultrasound imaging system 91)] takes place across at least one of a wireless connection or an optical connection (see, e.g., Para. [0030], “According to the embodiment shown in FIG. 1, the needle tracking system 93 is a magnetic tracking system and it includes an emitter 122 disposed in the probe 106 and a sensor 124 disposed in the needle 90. According to an exemplary embodiment, the emitter 122 may comprise a magnetic sensor board. The magnetic sensor board includes a magnetic field generator configured to emit an electromagnetic field of a known direction and intensity. The sensor 124 disposed in the needle 90 may include three sets of coils […] By detecting the currents induced in each of the coils, position and orientation information may be determined from the sensor 124. According to an embodiment, the processor 116 is in electronic communication with the needle tracking system 93. For example, the probe 106 may be connected to the processor 116 via either a wired or a wireless connection. Likewise, position data from the sensor 124 may be communicated to the processor 116 via either a wired connection or through wireless techniques”, and Fig. 1, where the sensor 124 of the needle 90, needle tracking system 93 communicates to the processor 116 via the sensor’s connection to the probe 106, in which each of the connections may be through wireless techniques).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the medical ultrasound system of Miller modified by Halmann and Long by including wherein the exchanging the data takes place across at least one of a wireless connection or an optical connection, as disclosed by Halmann ‘399. One of ordinary skill in the art would have been motivated to make this modification in order to desirably determine position and orientation information from the sensor by detecting the currents induced in each of the coils on the sensor, as recognized by Halmann ‘399 (see, e.g., Para. [0025] and [0030]), and further using a wireless connection to transmit data is a known effective alternative to using a wired connection, as recognized by Halmann ’399 (see, e.g., Para. [0030]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Miller (US Patent No. 5,758,650 A) in view of Halmann (US 2015/0209003 A1) and Long (US 2017/0196591 A1), as applied to claim 1 above, and further in view of Keenan (WO 2004/082749 A2, of record, a copy of which was provided by the examiner and herein used for citation, hereinafter Keenan).
Regarding claim 10, Miller modified by Halmann and Long discloses the medical ultrasound system of claim 1, as set forth above. Halmann further discloses wherein the accessory interface apparatus (needle tracking system 40, cables 60, console 70) is coupled to the one or more optional accessories (needle 30) (see, e.g., Para. [0011], “Referring to FIG. 1, an ultrasound probe head 10 is placed adjacent to living tissue 20, such as human tissue. A needle tracking system 40 is attached to the probe head 10 and measures the depth and angle of insertion of a hollow needle 30. […] The probe head 10 is connected to cables 60 which are, in turn, connected to an ultrasound console 70. The console 70 has a processor for receiving and manipulating signals received from both the probe head 10 and the needle tracking system 40”, and Para. [0012], “In one embodiment, the needle tracking system 40 supplies data to the console 70 from which an estimate of the position of the needle 30 is formulated and may be graphically represented a feature 80. In one embodiment, the data from the needle tracking system 40 includes the angle of insertion, the depth of insertion, and the angle of insertion of needle 30 into tissue 20. This data is used to provide a predicted position 80 of needle 30”, and Para. [0013], “In one embodiment needle tracking system 40 may rely upon signals obtained from the needle 30. The needle 30 or a portion thereof may be magnetized and needle tracking system 40 may rely on magnetic interactions with the needle 30. The needle 30 may be provided with a radio frequency identification (RFID) tag and the tag may be probed by the needle tracking system 40. The needle tracking system 40 may rely upon any of the known optical, mechanical, magnetic or electro-magnetic tracking technologies that provides a reasonable estimate of the location of a needle 30 inserted into living tissue 20”).
Miller modified by Halmann and Long does not specifically disclose wherein the accessory interface apparatus provides power to the one or more optional accessories.
However, in the same field of endeavor of ultrasound needle guidance, Keenan discloses wherein the accessory interface apparatus (assembly 5, power source 15, RF control 54) provides power to the one or more optional accessories (needle 6, radiofrequency probes 53) (see, e.g., Page 23, lines 18-28 and Page 24, lines 1-2, “Figure 9A depicts the invention being used to position a needle under real-time ultrasound guidance. An ultrasound transducer (1) transmits and receives pulses in order to image the interior of a patient (2) on an ultrasound display (3). The handheld assembly (5) is used to insert a needle (6) into the patient towards the desired point of action (4), such as a solid tumor. Fluid 1, the echogenic fluid, (19), is ejected from the distal tip of the needle (7) at sufficient speed and for sufficient travel distance as to be detectable by the ultrasound. Radiofrequency probes (53) inside the needle (6) are connected through a sealed needle adaptor (26) to the RF control (54) and power source (15)”, where the power source 15 provides power to the radiofrequency probes 53 inside the needle 6 via the connection through the sealed needle adaptor 26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the medical ultrasound system of Miller modified by Halmann and Long by including wherein the accessory interface apparatus provides power to the one or more optional accessories, as disclosed by Keenan. One of ordinary skill in the art would have been motivated to make this modification in order to desirably position a needle under real-time ultrasound guidance, as recognized by Keenan (see, e.g., Page 23, lines 18-28 and Page 24, lines 1-2).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Miller (US Patent No. 5,758,650 A) in view of Halmann (US 2015/0209003 A1) and Long (US 2017/0196591 A1), as applied to claim 1 above, and further in view of Ahn et al. (US 2015/0011887 A1, of record, cited in the applicant’s IDS filed on 09/19/2022, hereinafter Ahn).
Regarding claim 12, Miller modified by Halmann and Long discloses the medical ultrasound system of claim 1, as set forth above. Miller modified by Halmann and Long does not disclose wherein the accessory interface apparatus is configured to provide output to a clinician via one or more of: a number of illuminating devices; an audio device; and a haptic device.
However, in the same field of endeavor of ultrasound systems, Ahn discloses wherein the accessory interface apparatus (object information providing unit 140) is configured to provide output to a clinician via one or more of: a number of illuminating devices (see, e.g., Para. [0061], “as illustrated in FIG. 5, the object information providing unit 140 includes the light-emitting unit LE. The light-emitting unit LE emits light according to a control of the processing unit 130 to output the object information TOI that shows a position of an object via light as illustrated in FIG. 5. The light-emitting unit LE, as illustrated in FIG. 5, is mounted on one side of the ultrasound probe 110”); an audio device (see, e.g., Para. [0060], “the object information providing unit 140 includes a speaker (not shown). The speaker outputs object information (i.e., an alarm sound) according to a control of the processing unit 130. For example, the speaker is mounted on one side of the ultrasound probe 110. However, the speaker may be disposed at a position which enables a user to hear the alarm sound output therefrom”); and a haptic device (see, e.g., Para. [0063], “the object information providing unit 140 include a vibration unit (not shown). The vibration unit is driven according to a control of the processing unit 130 to output object information that shows a position of an object as vibration. The vibration unit is mounted on one side of the ultrasound probe 110”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the medical ultrasound system of Miller modified by Halmann and Long by including wherein the accessory interface apparatus is configured to provide output to a clinician via one or more of: a number of illuminating devices; an audio device; and a haptic device, as disclosed by Ahn. One of ordinary skill in the art would have been motivated to make this modification in order to desirably output the obtained object information, as recognized by Ahn (see, e.g., Abstract, and Para. [0060-0063]).
Claims 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (US Patent No. 5,758,650 A) in view of Halmann (US 2015/0209003 A1) and Long (US 2017/0196591 A1), as applied to claims 1 and 18 above, and further in view of Durfee (US 2019/0307419 A1, of record, hereinafter Durfee).
Regarding claim 17, Miller modified by Halmann and Long discloses the medical ultrasound system of claim 1, as set forth above. Miller modified by Halmann and Long does not disclose wherein: the one or more optional accessories include an elongate probe having a number of electrodes disposed along a length of the elongate probe, the input includes electrical signals, and the operations further include processing the electrical signals to determine one or both of a bio-impedance of a substance adjacent the elongate probe and an ECG waveform.
However, in the same field of endeavor of medical ultrasound systems, Durfee discloses wherein: the one or more optional accessories include an elongate probe having a number of electrodes disposed along a length of the elongate probe, the input includes electrical signals, and the operations further include processing the electrical signals to determine one or both of a bio-impedance of a substance adjacent the elongate probe and an ECG waveform (see, e.g., Para. [0025], “Also disclosed herein is a medical device-placing system including, in some embodiments, an ultrasound probe, a medical-device TLS, a stylet, and a processing means configured for processing echoed ultrasound signals, TLS signals, and a set of electrocardiogram (“ECG”) signals. The ultrasound probe is configured to emit ultrasound signals into a patient and receive the echoed ultrasound signals from the patient by way of a piezoelectric sensor array. The TLS is configured for placement on a chest of the patient. The stylet is configured for insertion into a lumen of a medical device. The stylet includes an ECG electrode in a distal-end portion of the stylet configured to generate the set of ECG signals in response to electrical changes associated with depolarization and repolarization of a heart of the patient. The processing means includes electronic circuitry including memory and a processor configured to transform the echoed ultrasound signals to produce ultrasound-image segments corresponding to anatomical structures of the patient, transform the TLS signals from the TLS into location information for the medical device within the patient when the TLS is placed on the chest of the patient, and transform the set of ECG signals into an ECG”, and Para. [0133], [0144], and [0147]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the medical ultrasound system of Miller modified by Halmann and Long by including wherein: the one or more optional accessories include an elongate probe having a number of electrodes disposed along a length of the elongate probe, the input includes electrical signals, and the operations further include processing the electrical signals to determine one or both of a bio-impedance of a substance adjacent the elongate probe and an ECG waveform, as disclosed by Durfee. One of ordinary skill in the art would have been motivated to make this modification in order to desirably track and display advancement of the guidewire or catheter to a desired location while providing sets of ECG signals used to animate the heart of the patient when displayed as an object of virtual anatomy on the display screen, as recognized by Durfee (see, e.g., Para. [0147]).
Regarding claim 19, Miller modified by Halmann and Long discloses the accessory interface apparatus of claim 18, as set forth above. Miller modified by Halmann and Long does not disclose wherein the input includes one or both of optical signals that include reflected light having different spectral widths, and electrical signals that include an impedance measurement or an ECG signal.
However, in the same field of endeavor of medical ultrasound systems, Durfee discloses wherein the input includes one or both of optical signals that include reflected light having different spectral widths, and electrical signals that include an impedance measurement or an ECG signal (see, e.g., Para. [0025], “Also disclosed herein is a medical device-placing system including, in some embodiments, an ultrasound probe, a medical-device TLS, a stylet, and a processing means configured for processing echoed ultrasound signals, TLS signals, and a set of electrocardiogram (“ECG”) signals. The ultrasound probe is configured to emit ultrasound signals into a patient and receive the echoed ultrasound signals from the patient by way of a piezoelectric sensor array. The TLS is configured for placement on a chest of the patient. The stylet is configured for insertion into a lumen of a medical device. The stylet includes an ECG electrode in a distal-end portion of the stylet configured to generate the set of ECG signals in response to electrical changes associated with depolarization and repolarization of a heart of the patient. The processing means includes electronic circuitry including memory and a processor configured to transform the echoed ultrasound signals to produce ultrasound-image segments corresponding to anatomical structures of the patient, transform the TLS signals from the TLS into location information for the medical device within the patient when the TLS is placed on the chest of the patient, and transform the set of ECG signals into an ECG”, and Para. [0133], [0144], and [0147]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the accessory interface apparatus of Miller modified by Halmann and Long by including wherein the input includes one or both of optical signals that include reflected light having different spectral widths, and electrical signals that include an impedance measurement or an ECG signal, as disclosed by Durfee. One of ordinary skill in the art would have been motivated to make this modification in order to desirably track and display advancement of the guidewire or catheter to a desired location while providing sets of ECG signals used to animate the heart of the patient when displayed as an object of virtual anatomy on the display screen, as recognized by Durfee (see, e.g., Para. [0147]).
Response to Arguments
Applicant’s arguments, see Remarks filed 04/13/2026, with respect to the claim rejections under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Examiner notes that independent claims 1 and 18 are now rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US Patent No. 5,758,650 A) in view of Halmann et al. (US 2015/0209003 A1), and further in view of Long, Jr. et al. (US 2017/0196591 A1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following references are herein made of record and are each in the relevant field of endeavor of medical ultrasound systems/probes: Muller et al. (US 2020/0281561 A1), Holl et al. (US 2014/0243671 A1), Ko et al. (US 2017/0290568 A1), Valois et al. (US 2024/0225597 A1, with effectively filed date 02/12/2021), Eibl et al. (CN 108778146 A, a copy of which and a machine-generated English translation of which are both herein provided by the examiner), and Rousseau et al. (FR 3 119 752, a copy of which and a machine-generated English translation of which are both herein provided by the examiner).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/T.D./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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