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 Objections
Claims 91 and 92 are objected to because of the following informalities: “including;” should state “including:”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 101-103 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims rely on “means for” to perform the functions set forth in the claims. The term “means for” is a nonce term which does not have a known hardware or software embodiment in the art. The written description does not provide a corresponding structure or algorithm to transform a general purpose computer into a specialized computer.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 79-103 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 79, 91, 93, 98 and 101 recite the limitation "the algorithm" in line 6. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending the limitation to state “the vessel detection algorithm”.
Claim 88 recites the limitation “the vessel parameters” in line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear as to whether the claim is referring back to “preceding vessel parameters”, “current vessel parameters” or a different set of vessel parameters.
Claim 96 recites the limitation “the tracking algorithm” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 101-103 rely on “means for” to perform the functions set forth in the claims. The term “means for” is a nonce term which does not have a known hardware or software embodiment in the art. The written description does not provide a corresponding structure or algorithm to transform a general purpose computer into a specialized computer. It is unclear as to what considered “means for”.
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.
Claim(s) 79-82, 84-87, 91-93, 98 and 101 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brandl et al (2021/0315538) in view of Misener et al (2022/0172354).
Regarding claims 79 and 87, Brandl et al disclose an apparatus of a computing device comprising a memory, and one or more processors coupled to the memory (memory 120 and processor 116 – fig.1) to:
perform a vessel detection algorithm to detect, in real time during image generation by an ultrasound imaging device, a vessel of a living body (detection module 212 – [0031]; fig.2), the algorithm including:
determining current vessel parameters based on a current ultrasonic image frame on a display at a current time (acquires a B-mode image or grayscale ultrasound image of the vessel – [0070]);
determining preceding vessel parameters ( based on a preceding ultrasound image frame on the display at a time preceding the current time (loads ultrasound data including Doppler measurements for a vessel acquired during a previous ultrasound scan of a patient – [0070]; displays the flow profile from the previous ultrasound scan retrieved – [0071]);
determining current flow data for vessel fluid flow corresponding to the current ultrasonic image frame (as well as the flow profile from the current ultrasound scan – [0071]); and
detecting and tracking the vessel based on the current vessel parameters, the preceding vessel parameters and the current flow data (the user may review both flow profiles to monitor disease progression or treatment effect – [0071]); and
determine and cause to display to a user, via a user interface device that including the display, information (user interface for ultrasound imaging – [0019]; fig.4).
Brandl et al fail to explicitly disclose determine and cause to display to a user, via a user interface device that includes the display, information regarding a suitability of the vessel for access by a predetermined foreign object during performance of a vessel detection algorithm.
However, Misener et al teach in the same medical field of endeavor, determine and cause to display to a user, via a user interface device that includes the display, information regarding a suitability of a vessel for access by a predetermined foreign object during performance of a vessel detection algorithm (determine a suitable insertion site – [0036] by distinguishing arteries from veins based on, at least blood vessel differentiating characteristics – [0002]; one or more logic modules…distinguishing the artery from the vein – [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the vessel detection algorithm of Brandl et al with determining information regarding a suitability of the vessel for access by a predetermined foreign object of Misener et al as it would provide personalized tracking of treatment for a patient.
Regarding claim 80, Brandl et al disclose wherein the current flow data corresponds to current Doppler flow data, and the ultrasonic image is a two-dimensional ultrasonic image (Acquire ultrasound image and Doppler measurements of the vessel 1215 – fig.12).
Regarding claim 81, Brandl et al disclose wherein the one or more processors are to select determining the current flow data for a same field of view as the current ultrasonic image frame (fig.12) as well as changing a scanning parameter -[0022], but fail to explicitly disclose select between determining the current flow data for a same field of view and for a smaller field of view than the same field of view.
However, Misener et al teach in the same medical field of endeavor, select between determining a current flow data for a same field of view and for a smaller field of view than a same field of view (changing the anatomical frame of reference may include altering the visualization to include more or fewer other anatomical characteristics and/or generating the ultrasound image at a different angle relative to the blood vessel or fluid or body cavities -[0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the determining the current flow data for a same field of view as the current ultrasonic image frame of Brandl et al with determining the current flow data for a smaller field of view than the same field of view of Misener et al as it would provide generation for a specific location of interest within the original field of view.
Regarding claim 82, Brandl et al as modified by Misener et al disclose the invention as claimed and discussed above. Misener et al further teach wherein the one or more processors are to select to determine the current flow for the same field of view at a start of image generation, and to subsequently select to determine the current flow data for the smaller field of view (identify within an anatomical frame of reference, wherein the anatomical frame of reference may include an ultrasound image, and changing the anatomical frame of reference may include altering the visualization to include more or few other anatomical characteristics – [0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the determination of current flow data of Brandl eta l with subsequently selecting to determine for the smaller field of view as it would provide an initial current flow data for the entire field of view and a subsequent current flow data for a region of interest within said entire field of view.
Regarding claim 84, Brandl et al disclose wherein the one or more processors are to further cause the user interface device to communicate to the user information on the current flow data in real time during the image generation (the data may be processed in real-time during a scanning session – [0023]).
Regarding claim 85, Brandl et al disclose wherein the one or more processors are to further determine and cause to display to the user, via the user interface device, information regarding the current vessel parameters (fig.4).
Regarding claim 86, Brandl et al disclose wherein the information regarding the current vessel parameters includes an outline of a boundary of the vessel and at least one of a location of its center or its diameter on the current ultrasonic image frame (region of interest (ROI) 409 – fig.4).
Regarding claim 91, Brandl et al disclose a system including:
a user interface device including a display device (user interface for ultrasound imaging – [0019]; fig.4); and
a computing device communicatively coupled to the user interface device, the computing device comprising a memory, and one or more processors coupled to the memory (memory 120 and processor 116 – fig.1) to:
perform a vessel detection algorithm to detect, in real time during image generation by an ultrasound imaging device, a vessel of a living body (detection module 212 – [0031]; fig.2), the algorithm including:
determining current vessel parameters based on a current ultrasonic image frame on a display at a current time (acquires a B-mode image or grayscale ultrasound image of the vessel – [0070]);
determining preceding vessel parameters ( based on a preceding ultrasound image frame on the display at a time preceding the current time (loads ultrasound data including Doppler measurements for a vessel acquired during a previous ultrasound scan of a patient – [0070]; displays the flow profile from the previous ultrasound scan retrieved – [0071]);
determining current flow data for vessel fluid flow corresponding to the current ultrasonic image frame (as well as the flow profile from the current ultrasound scan – [0071]); and
detecting and tracking the vessel based on the current vessel parameters, the preceding vessel parameters and the current flow data (the user may review both flow profiles to monitor disease progression or treatment effect – [0071]); and
determine and cause to display to a user, via a user interface device that including the display, information (user interface for ultrasound imaging – [0019]; fig.4).
Brandl et al fail to explicitly disclose determine and cause to display to a user, via a user interface device that includes the display, information regarding a suitability of the vessel for access by a predetermined foreign object.
However, Misener et al teach in the same medical field of endeavor, determine and cause to display to a user, via a user interface device that includes the display, information regarding a suitability of a vessel for access by a predetermined foreign object (determine a suitable insertion site – [0036] by distinguishing arteries from veins based on, at least blood vessel differentiating characteristics – [0002]; one or more logic modules…distinguishing the artery from the vein – [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the vessel detection algorithm of Brandl et al with determining information regarding a suitability of the vessel for access by a predetermined foreign object of Misener et al as it would provide personalized tracking of treatment for a patient.
Regarding claim 92, Brandl et al disclose wherein the vessel parameters include vessel pulsatility ([0045]).
Regarding claim 93, Brandl et al disclose a method to be performed at a computing device comprising a memory, and one or more processors coupled to the memory (memory 120 and processor 116 – fig.1), the method including:
perform a vessel detection algorithm to detect, in real time during image generation by an ultrasound imaging device, a vessel of a living body (detection module 212 – [0031]; fig.2), the algorithm including:
determining current vessel parameters based on a current ultrasonic image frame on a display at a current time (acquires a B-mode image or grayscale ultrasound image of the vessel – [0070]);
determining preceding vessel parameters ( based on a preceding ultrasound image frame on the display at a time preceding the current time (loads ultrasound data including Doppler measurements for a vessel acquired during a previous ultrasound scan of a patient – [0070]; displays the flow profile from the previous ultrasound scan retrieved – [0071]);
determining current flow data for vessel fluid flow corresponding to the current ultrasonic image frame (as well as the flow profile from the current ultrasound scan – [0071]); and
detecting and tracking the vessel based on the current vessel parameters, the preceding vessel parameters and the current flow data (the user may review both flow profiles to monitor disease progression or treatment effect – [0071]); and
determine and cause to display to a user, via a user interface device that including the display, information (user interface for ultrasound imaging – [0019]; fig.4).
Brandl et al fail to explicitly disclose determine and cause to display to a user, via a user interface device that includes the display, information regarding a suitability of the vessel for access by a predetermined foreign object.
However, Misener et al teach in the same medical field of endeavor, determine and cause to display to a user, via a user interface device that includes the display, information regarding a suitability of a vessel for access by a predetermined foreign object (determine a suitable insertion site – [0036] by distinguishing arteries from veins based on, at least blood vessel differentiating characteristics – [0002]; one or more logic modules…distinguishing the artery from the vein – [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the vessel detection algorithm of Brandl et al with determining information regarding a suitability of the vessel for access by a predetermined foreign object of Misener et al as it would provide personalized tracking of treatment for a patient.
Regarding claim 98, Brandl et al disclose one or more computer-readable media comprising a plurality of instructions stored thereon that, when executed, cause one or more processors, are to cause the one or more processors to perform operations including: perform a vessel detection algorithm to detect, in real time during image generation by an ultrasound imaging device, a vessel of a living body (detection module 212 – [0031]; fig.2), the algorithm including:
determining current vessel parameters based on a current ultrasonic image frame on a display at a current time (acquires a B-mode image or grayscale ultrasound image of the vessel – [0070]);
determining preceding vessel parameters ( based on a preceding ultrasound image frame on the display at a time preceding the current time (loads ultrasound data including Doppler measurements for a vessel acquired during a previous ultrasound scan of a patient – [0070]; displays the flow profile from the previous ultrasound scan retrieved – [0071]);
determining current flow data for vessel fluid flow corresponding to the current ultrasonic image frame (as well as the flow profile from the current ultrasound scan – [0071]); and
detecting and tracking the vessel based on the current vessel parameters, the preceding vessel parameters and the current flow data (the user may review both flow profiles to monitor disease progression or treatment effect – [0071]); and
determine and cause to display to a user, via a user interface device that including the display, information (user interface for ultrasound imaging – [0019]; fig.4).
Brandl et al fail to explicitly disclose determine and cause to display to a user, via a user interface device that includes the display, information regarding a suitability of the vessel for access by a predetermined foreign object.
However, Misener et al teach in the same medical field of endeavor, determine and cause to display to a user, via a user interface device that includes the display, information regarding a suitability of a vessel for access by a predetermined foreign object (determine a suitable insertion site – [0036] by distinguishing arteries from veins based on, at least blood vessel differentiating characteristics – [0002]; one or more logic modules…distinguishing the artery from the vein – [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the vessel detection algorithm of Brandl et al with determining information regarding a suitability of the vessel for access by a predetermined foreign object of Misener et al as it would provide personalized tracking of treatment for a patient.
Regarding claim 101, Brandl et al disclose an apparatus of a computing device comprising:
means for performing a vessel detection algorithm to detect, in real time during image generation by an ultrasound imaging device, a vessel of a living body (detection module 212 – [0031]; fig.2), the algorithm including:
determining current vessel parameters based on a current ultrasonic image frame on a display at a current time (acquires a B-mode image or grayscale ultrasound image of the vessel – [0070]);
determining preceding vessel parameters ( based on a preceding ultrasound image frame on the display at a time preceding the current time (loads ultrasound data including Doppler measurements for a vessel acquired during a previous ultrasound scan of a patient – [0070]; displays the flow profile from the previous ultrasound scan retrieved – [0071]);
determining current flow data for vessel fluid flow corresponding to the current ultrasonic image frame (as well as the flow profile from the current ultrasound scan – [0071]); and
detecting and tracking the vessel based on the current vessel parameters, the preceding vessel parameters and the current flow data (the user may review both flow profiles to monitor disease progression or treatment effect – [0071]).
Brandl et al fail to explicitly disclose means for determining information regarding a suitability of the vessel for access by a predetermined foreign object.
However, Misener et al teach in the same medical field of endeavor, means for determining information regarding a suitability of a vessel for access by a predetermined foreign object (determine a suitable insertion site – [0036] by distinguishing arteries from veins based on, at least blood vessel differentiating characteristics – [0002]; one or more logic modules…distinguishing the artery from the vein – [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the vessel detection algorithm of Brandl et al with determining information regarding a suitability of the vessel for access by a predetermined foreign object of Misener et al as it would provide personalized tracking of treatment for a patient.
Claim(s) 83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brandl et al (2021/0315538) in view of Misener et al (2022/0172354) as applied to claim 82 above, and further in view of Liew et al (20040242987).
Regarding claim 83, Brandl et al as modified by Misener et al disclose the invention as claimed and discussed above, but fail to explicitly disclose wherein the smaller field of view includes a predetermined number of image pixels to a at least one of a left, right, bottom or top edge of the same field of view.
However, Liew et al teach in the same medical field of endeavor, wherein a smaller field of view includes a predetermined number of image pixels to a at least one of a left, right, bottom or top edge of a same field of view (the analysis can be applied to clusters of pixels or voxels wherein the size of the clusters is typically selected to represent a compromise between spatial resolution and processing speed – [0061]; figs.2A-2C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the smaller field of view of Brandl et al as modified by Misener et al with a predetermined number of image pixels to at least a left, right, bottom or top edge of the same field of view as it would provide a pixel-by-pixel assessment of parameters of a size cluster chosen to optimize data analysis.
Allowable Subject Matter
Claims 88-90, 94-97, 99 and 100 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 102 and 103 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) and (b) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph or 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
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/ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797