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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 7-12 is/are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Blanchard et al. (US 20220104886, as cited in the 08/28/2024 IDS, hereinafter Blanchard).
Regarding claim 1, Blanchard teaches an ultrasound probe (ultrasound probe 104 in fig. 1 or probe 204 in fig. 3), comprising:
a probe head including an array of ultrasonic transducers ([0075] “the plurality of ultrasonic transducers 110 arranged in an array in the probe head 208”. [0064]) configured to emit generated ultrasound signals into a target area of a patient, receive reflected ultrasound signals from the patient ([0030] “the ultrasound probe emits generated ultrasound signals into the patient from ultrasonic transducers in the probe head and receives reflected ultrasound signals from the patient by the ultrasonic transducers”. [0030] further discloses the identifying a target within the patient under the probe head from the image generated from the received signals. Therefore the emitted signals are sent into a target area of the patient), and convert the reflected ultrasound signals into corresponding electrical signals ([0080] discloses receiving, amplifying, and digitizing the reflected ultrasound signals);
a light source configured to project a visual indication onto a skin surface of the patient ([0067] “the light-pattern projector 114 is configured to project a light pattern 122 in the spatial region about the probe head 108”. Fig. 6 shows the pattern is projected on the skin); and
a console coupled with the probe head and the light source (fig. 1 discloses console 102 connected to the probe head and light source), the console including a signal converter configured to convert the electrical signals into ultrasound image data including an ultrasound image of the target area ([0080] discloses performing image processing to generate ultrasound images 136), one or more processors (the electronic circuitry of the console), and a non-transitory computer-readable medium having stored thereon logic that ([079] discloses the console 102 includes a memory for storing programmable read only memory for controlling the system), when executed by the one or more processors, causes operations including:
performing a determination process on the ultrasound image data to determine when an anatomical target is present within the ultrasound image ([0081] discloses determining the depth of the anatomical structure within the ultrasound images 136, thereby performing a determination process that the anatomical target is present in the image); and
activating the light source to project the visual indication onto the skin surface (fig. 6 discloses activating the light source to project the pattern on the skin), the visual indication including one or more visual characteristics based on one or more characteristics of the anatomical target ([0081] discloses adjusting a scale of the pattern 122 based on the depth (anatomical characteristic) of the anatomical structure).
Regarding claim 7, Blanchard teaches the probe of claim 1, as set forth above. Blanchard further teaches the one or more visual characteristics includes at least one of a dot or a line (figs. 6-8 show the visual characteristics include at least a line).
Regarding claim 8, Blanchard teaches the probe of claim 7, as set forth above. Blanchard further teaches the one or more visual characteristics include the line, and wherein the line is configured to extend away from the ultrasound probe in a direction perpendicular to a front face of the ultrasound probe (figs. 6 and 7 show the pattern 122 includes a line that extends away from the ultrasound probe 104/204 in a direction perpendicular to the front face of the probe).
Regarding claim 9, Blanchard teaches the probe of claim 1, as set forth above. Blanchard further teaches the one or more characteristics of the anatomical target include at least one of an identity of the anatomical target or a location of the anatomical target with respect to the ultrasound probe ([0081] and fig. 4 disclose determining the depth of the anatomical structure within the image which corresponds to the depth the anatomical structure is from the probe head which reads on determining a location of the anatomical target with respect to the ultrasound probe).
Regarding claim 10, Blanchard teaches the probe of claim 9, as set forth above. Blanchard further teaches the operations further include performing a location process on the ultrasound image data to determine the location of the anatomical target with respect to the ultrasound probe ([0081] and fig. 4 disclose determining the depth of the anatomical structure within the image which corresponds to the depth (location) the anatomical structure is from the probe head).
Regarding claim 11, Blanchard teaches the probe of claim 10, as set forth above. Blanchard further teaches activating the light source includes projecting the visual indication onto the skin surface at a location above the anatomical target (fig. 6 shows the activation of the light source to generate the pattern includes projecting the pattern on the skin at a location above the anatomical target (blood vessel)).
Regarding claim 12, Blanchard teaches the probe of claim 11, as set forth above. Blanchard further teaches the location of the visual indication defines an insertion site for a needle to access the anatomical target (fig. 6 shows the location of the pattern defines an insertion site for the needle 116 to access the anatomical target (blood vessel)).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard in view of Bouazza-Marouf et al. (US 20190282262, hereinafter Bouazza).
Regarding claim 2, Blanchard teaches the probe of claim 1, as set forth above. Blanchard does not specifically teach the light source includes a separate light source module attached to and operably coupled with the ultrasound probe.
However,
Bouazza in a similar field of endeavor teaches the light source includes a separate light source module attached to and operably coupled with the ultrasound probe ([0045] discloses the marking guide is a laser/light guide attached to the probe).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the light source include a separate light source module attached to and operably coupled with the ultrasound probe of Bouazza to the probe of Blanchard to allow for the predictable results of increasing the mobility and versatility of the probe by not limiting it to be used for the sole purpose of having a light guide.
Regarding claim 3, Blanchard in view of Bouazza teaches the probe of claim 2 as set forth above. Bouazza further teaches the separate light source module is configured to attach to and operably couple with the ultrasound probe having a sterile barrier covering the probe, the sterile barrier disposed between the separate light source module and the ultrasound probe ([0412] discloses the US probe is placed into a sterile cover and then the marking bracket (light source) is then fixed to the probe. [0471]-[0472] additionally discloses “the bracket can be mounted externally to the cover without damaging the cover and can serve to hold the cover tightly around the end of the probe”).
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 probe system disclosed by Blanchard to have the separate light source module is configured to attach to and operably couple with the ultrasound probe having a sterile barrier covering the probe, the sterile barrier disposed between the separate light source module and the ultrasound probe in order to improve patient outcomes, as recognized by Bouazza ([0020]).
Regarding claim 4, Blanchard in view of Bouazza teaches the probe of claim 2 as set forth above. Bouazza further teaches the separate light source module is wirelessly coupled with the ultrasound probe ([0301] discloses the marking guide includes laser/light pointer. [0381]-[0382] discloses the parts of the marking bracket guide are wirelessly connected to the system).
Regarding claim 5, Blanchard in view of Bouazza teaches the probe of claim 2 as set forth above. Bouazza further teaches the separate light source module is configured for single use ([0471] discloses the bracket is mounted on the probe and is therefore detachable and configured for single use).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard in view of Ito et al. (US 20130296651, hereinafter Ito).
Regarding claim 6, Blanchard teaches the probe of claim 1, as set forth above. Blanchard does not specifically teach the operations further include deactivating the light source when the anatomical target is not present within the ultrasound image.
However,
Ito in a similar field of endeavor teaches the operations further include deactivating the light source when the target is not present within the ultrasound image ([0008] and [0094] disclose stopping the illumination of the light when it is determined when the insertion portion (target) is not present within an observation target (image)).
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 probe system disclosed by Blanchard to have the operations further include deactivating the light source when the anatomical target is not present within the ultrasound image in order to extend the light of the light source, as recognized by Ito ([0094]).
Claim(s) 13 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard in view of Messerly et al. (US 20220160434, hereinafter Messerly).
Regarding claim 13, Blanchard teaches the probe of claim 9, as set forth above. Blanchard does not specifically teach the operations further include performing an identification process on the ultrasound image data to identify the anatomical target as a vein or as an anatomical element other than a vein.
However,
Messerly in a similar field of endeavor teaches the operations further include performing an identification process on the ultrasound image data to identify the anatomical target as a vein or as an anatomical element other than a vein ([0072] discloses the system classifies the target by identifying whether the target is a vein or artery).
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 probe system disclosed by Blanchard to have the operations further include performing an identification process on the ultrasound image data to identify the anatomical target as a vein or as an anatomical element other than a vein in order to improve clinical accuracy, as recognized by Messerly ([0075]).
Regarding claim 17, Blanchard teaches the probe of claim 10, as set forth above. Blanchard does not specifically teach performing the location process includes applying a first trained machine-learning model to the ultrasound image data resulting in the determination of the location of the anatomical target with respect to the ultrasound probe.
However,
Messerly in a similar field of endeavor teaches performing the location process includes applying a first trained machine-learning model to the ultrasound image data resulting in the determination of the location of the anatomical target with respect to the ultrasound probe ([0071] discloses using a machine learning method to identify specific targets within the image. [0066] “the disclosed system can simultaneously determine the location of anatomical targets”).
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 probe system disclosed by Blanchard to have performing the location process include applying a first trained machine-learning model to the ultrasound image data resulting in the determination of the location of the anatomical target with respect to the ultrasound probe in order to improve clinical accuracy, as recognized by Messerly ([0075]).
Regarding claim 18, Blanchard in view of Messerly teaches the probe of claim 13, as set forth above. Messerly further teaches performing the identification process includes applying a second trained machine-learning model to the ultrasound image data resulting in the identification of the anatomical target as the vein or as the anatomical element other than a vein ([0084] discloses using an AI model to classify the potential targets such as blood vessels. [0072]-[0073]).
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 probe system disclosed by Blanchard to have performing the identification process includes applying a second trained machine-learning model to the ultrasound image data resulting in the identification of the anatomical target as the vein or as the anatomical element other than a vein in order to improve clinical accuracy, as recognized by Messerly ([0075]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard in view of Messerly as applied to claim 13 above, and further in view of Kadokura et al. (US 20240050060, hereinafter Kadokura).
Regarding claim 14, Blanchard in view of Messerly teaches the probe of claim 13, as set forth above. Blanchard in view of Messerly does not specifically teach the one or more visual characteristics include a number of colors.
However,
Kadokura in a similar field of endeavor teaches the one or more visual characteristics include a number of colors ([0079] discloses the laser pointer outputs a color beam).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the one or more visual characteristics include a number of colors of Kadokura to the probe system disclosed by Blanchard in view of Messerly to allow for the predictable results of increasing the visibility of the visual indication.
Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard in view of Meurer et al. (US 20120179038, hereinafter Meurer).
Regarding claim 19, Blanchard teaches the probe of claim 10, as set forth above. Blanchard does not specifically teach the ultrasound probe is operably coupled with a needle tracking system configured to determine a location and an orientation of a trackable needle with respect to the ultrasound probe, the operations further including: receiving needle tracking data from the needle tracking system; and performing a tracking process on the ultrasound image data in combination with the needle tracking data to determine a location of the trackable needle with respect to the anatomical target, and the one or more visual characteristics include visual characteristics based on the location of the trackable needle with respect to the anatomical target.
However,
Meurer in a similar field of endeavor teaches the ultrasound probe is operably coupled with a needle tracking system configured to determine a location and an orientation of a trackable needle with respect to the ultrasound probe (fig. 1 shows the probe 16 is operably coupled to the position/trajectory computation component 38 (needle tracking system) and [0020] discloses the component 38 calculates the orientation and physical location of the interventional instrument 34 (needle)), the operations further including: receiving needle tracking data from the needle tracking system ([0020] discloses “The control circuitry 26 may receive the interventional instrument 34 location and orientation data”); and performing a tracking process on the ultrasound image data in combination with the needle tracking data to determine a location of the trackable needle with respect to the anatomical target ([0025] discloses in step 58 it is determined whether the instrument (needle) is in the ultrasound plane, thereby determining the location of the instrument relative to the target since the target is in plane), and the one or more visual characteristics include visual characteristics based on the location of the trackable needle with respect to the anatomical target ([0025] discloses displaying the path of the instrument in a specific color based on whether the instrument is aligned with the target or not).
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 probe system disclosed by Blanchard to have the ultrasound probe be operably coupled with a needle tracking system configured to determine a location and an orientation of a trackable needle with respect to the ultrasound probe, the operations further including: receiving needle tracking data from the needle tracking system; and performing a tracking process on the ultrasound image data in combination with the needle tracking data to determine a location of the trackable needle with respect to the anatomical target, and the one or more visual characteristics include visual characteristics based on the location of the trackable needle with respect to the anatomical target in order to decrease complication and improve controllability of the procedure, as recognized by Meurer.
Regarding claim 20, Blanchard in view of Meurer teaches the probe of claim 19, as set forth above. Meurer further teaches the visual characteristics based on the location of the trackable needle are configured to indicate when the trackable needle is aligned with the anatomical target ([0025] discloses the color change indicates when the needle is aligned with the target).
Regarding claim 21, Blanchard in view of Meurer teaches the probe of claim 20, as set forth above. Meurer further teaches the visual characteristics based on the location of the trackable needle include: a fifth color when the tracking process determines that the trackable needle is not aligned with the anatomical target; and a sixth color different from the fifth color when the tracking process determines that the trackable needle is aligned with the anatomical target ([0025], [0027] and fig. 2 disclose displaying the path as green when the instrument is aligned with the target and as red when the instrument is not aligned with the target).
Allowable Subject Matter
Claims 15-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record fails to reasonably teach or in combination render obvious the following limitations when the claims taken as a whole to include, “the one or more visual characteristics include: a first color when the identification process identifies the anatomical target as a vein; and a second color, different from the first color, when the identification process identifies the anatomical target as the anatomical element other than a vein.”, where the visual characteristics specifically relate to the visual indications projected onto the skin surface of the subject using the light source.
Examiner notes the prior art reference Misener et al. (US 20230389893) discloses the limitation recited above in [0055], “The light projector 220 may indicate an artery versus a vein in other ways, such as projecting a color over a projected image of the blood vessel”. However, the Misener et al. reference cannot be applied as prior art as it falls within the 102(b)(1)(A) exception.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW BEGEMAN whose telephone number is (571)272-4744. The examiner can normally be reached Monday-Thursday 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at 5712701790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANDREW W BEGEMAN/Examiner, Art Unit 3798