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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/12/25 has been entered.
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 1, 3, 9-14, and 17-20 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.
In claims 1, 13, and 14, the limitations “said associated blood flow information also providing information about a cardiac cycle timing of said image” and “aligns the probe to correctly acquire a selected view of said of heart said subject, taking said cardiac cycle timing into account” are not mentioned in the specification and is considered new matter.
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 1, 3, 9-14, and 17-20 are 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.
In claims 1, 13, and 14, the limitation “said associated blood flow information also providing information about a cardiac cycle timing of said image” and “aligns the probe to correctly acquire a selected view of said of heart said subject, taking said cardiac cycle timing into account” renders the claim indefinite. The scope of the limitation “taking…into account” is unclear.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 9-14, and 17-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13, 21, 23, 25-31, and 33-43 of copending Application No. 18556123 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions are directed to systems and methods for guiding positioning and orienting of an ultrasound probe including receiving image data, analyzing the data, and conveying to the user of the probe the current position and orientation of the probe relative to the target position and orientation . Regarding claim 13 of the reference application, the claim differs from claim 1 of the instant invention in that it includes limitations regarding superimposing fluid flow information. However, it is noted that these features are described in claims 7-8 of the instant application. Furthermore, regarding the specific shape of the visual cues describes in claims 21 and 31 of the reference application, it would be within the level of one of ordinary skill in the art, without undue experimentation, to utilize visual cues having known shapes to convey the information regarding position of the probe and the target. In particular, a cross-hair reticle type view is known in the art of image processing/analysis, for aligning with a target in an image.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
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, 3, 9-11, 14, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kezurer et al. (US 2019/0354856; hereinafter Kezurer) in view of Takeuchi (US 2004/0019270), Mochizuki et al. (US 2019/0328317; hereinafter Mochizuki), and Sasaki et al. (US 2021/0161510; hereinafter Sasaki).
Kezurer shows a system and method for positioning and orienting an ultrasound probe (abstract), the method comprising: receiving a dataset derived from the ultrasound probe, ([0066]-[0067]; [0078]-[0079]); analyzing the dataset to identify a current position and orientation of the probe relative to a target position and orientation, wherein the target position and orientation align the probe to correctly acquire a selected view of a body part ([0066]-[0067]; [0078]-[0079]); and conveying, to a user of the probe, the current position and orientation of the probe relative to the target position and orientation ([0066]-[0067]; [0078]-[0079]).
Also, wherein the dataset comprises an image derived from signals obtained by the ultrasound probe ([0066]); wherein the dataset is received by monitoring a display in communication with the ultrasound probe ([0066]); wherein analyzing the dataset comprises using an artificial intelligence process ([0065], [0068]-[0069], [0110]); wherein the artificial intelligence process outputs at least one of: a current position and orientation of the ultrasound probe relative to the selected view ([0065], [0068]-[0069], [0110]); wherein the conveying comprises generating, based on at least a portion of the dataset, one or more images each comprising one or more visual cues indicating the current position and orientation, and causing a presentation of the one or more images on a display ([0066]-[0067]; [0078]-[0079]); wherein the one or more visual cues comprises at least one of an indication of a type, a direction, and a measure of motion required to bring the probe from its current position and orientation to its target position and orientation ([0066]-[0067]; [0078]-[0079]).
Kezurer fails to show wherein the dataset comprises at least ultrasound image and at least one blood flow information obtained together, said associated blood flow information also providing information about a cardiac cycle timing of said image; which aligns the probe taking said cardiac cycle into account. Also, wherein the at least one dataset obtained during a pulsed Doppler mode operation of the probe comprises an image and Doppler information; wherein the image is augmented with the Doppler information; wherein the analyzing comprises analyzing a motion within the body part based on pulsed Doppler mode information; wherein the motion is a motion of fluid within the body part.
Kezurer fails to show analyzing said at least one ultrasound image and said at least one blood flow information.
Kezurer fails to show using an artificial intelligence process trained on ultrasound images and blood flow information to take into account a relationship between a temporal degree of freedom within a cardiac cycle of fluid flow and at least one spatial degree of freedom, correctly acquire a selected view of a body part irrespective of whether or not a heart is in said selected view.
Takeuchi discloses guidance information for an ultrasonic diagnostic probe. Takeuchi teaches wherein the dataset comprises at least ultrasound image and at least one blood flow information obtained together, said associated blood flow information also providing information about a cardiac cycle timing of said image ([0036]); which aligns the probe taking said cardiac cycle into account (the provided Doppler information is considered to take the cardiac cycle into account as Doppler information is representative of the blood flow and related cardiac cycle timing of the patient; [0060]-[0061], Fig. 7A). Also, wherein the at least one dataset obtained during a pulsed Doppler mode operation of the probe comprises an image and Doppler information ([0036]; wherein the image is augmented with the Doppler information ([0036]); wherein the analyzing comprises analyzing a motion within the body part based on pulsed Doppler mode information ([0036]); wherein the motion is a motion of fluid within the body part ([0036]).
Mochizuki discloses an ultrasound diagnostic apparatus. Mochizuki teaches analyzing said at least one ultrasound image and said at least one blood flow information (calculate distance between blood vessel and body surface by analyzing the Doppler data and the B-mode data in combination; [0048], [0075]).
Sasaki discloses ultrasound diagnostic apparatus and methods. Sasaki teaches using an artificial intelligence process trained on ultrasound images and blood flow information to take into account a relationship between a temporal degree of freedom within a cardiac cycle of fluid flow and at least one spatial degree of freedom, correctly acquire a selected view of a body part irrespective of whether or not a heart is in said selected view (regardless of the type of blood vessel drawn in the ultrasonic image; [0055]-[0056], [0062]-[0063]).
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 invention of Kezurer to utilize Doppler information which provides cardiac cycle timing information as taught by Takeuchi, as the benefits of Doppler type data in the field of medical ultrasound diagnostics are known in the art, and in particular Doppler type imaging will obtain information regarding moving particles, such that blood flow information may be accurately determined and conveyed to the user in the images.
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 combined invention of Kezurer and Takeuchi to analyze the combination of the B-mode and Doppler data as taught by Mochizuki, as analyzing the B-mode and Doppler data in combination provides the complementary information from each of the modalities, where B-mode is particularly beneficial for analyzing structures within the image and where Doppler is particularly beneficial for analyzing blood flow, and where the benefits of each may be advantageously provided to the user.
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 combined invention of Kezurer, Takeuchi, and Mochizuki to utilize artificial intelligence methods trained on ultrasound images and blood flow information as taught by Sasaki, in order to provide an computer based technique which combines the obtained diagnostic information corresponding with B-mode ultrasound images and Doppler blood flow information in order to automatically produce a more accurate final displayed result by combining the complementary information in an automated machine learning technique.
Further, it should be noted that Kezurer recognizes that any suitable display or interface may be used to convey the information to the user (Kezurer, [0079]), and thus the use of different types of displays or user interfaces for the guidance information as described above would be an obvious modification to one of ordinary skill in the art.
Claim(s) 12, 17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kezurer et al. (US 2019/0354856; hereinafter Kezurer) in view of Takeuchi (US 2004/0019270), Mochizuki et al. (US 2019/0328317; hereinafter Mochizuki), and Sasaki et al. (US 2021/0161510; hereinafter Sasaki), as applied to claims 1, 14, and 18 above, and further in view of Cadieu et al. (US 2021/0052253; hereinafter Cadieu).
Kezurer fails to show wherein the conveying comprises presenting an image quality indication scale on a display.
Cadieu discloses displays for ultrasound diagnostics. Cadieu teaches wherein the conveying comprises presenting an image quality indication scale on a display ([0022]).
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 combined invention of Kezurer, Takeuchi, Mochizuki, and Sasaki, to display an image quality indication as taught by Cadieu, as this will aid in alerting the user when a poor image is obtained so that the user may be guided to obtain a higher quality image.
Claims 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kezurer et al. (US 2019/0354856; hereinafter Kezurer) in view of Takeuchi (US 2004/0019270), Mochizuki et al. (US 2019/0328317; hereinafter Mochizuki), Sasaki et al. (US 2021/0161510; hereinafter Sasaki), and Cadieu et al. (US 2021/0052253; hereinafter Cadieu).
Kezurer shows a system and method for positioning and orienting an ultrasound probe (abstract), the method comprising: receiving a dataset derived from the ultrasound probe, ([0066]-[0067]; [0078]-[0079]); analyzing the dataset to identify a current position and orientation of the probe relative to a target position and orientation, wherein the target position and orientation align the probe to correctly acquire a selected view of a body part ([0066]-[0067]; [0078]-[0079]); and conveying, to a user of the probe, the current position and orientation of the probe relative to the target position and orientation ([0066]-[0067]; [0078]-[0079]).
Also, wherein the dataset comprises an image derived from signals obtained by the ultrasound probe ([0066]); wherein the dataset is received by monitoring a display in communication with the ultrasound probe ([0066]); wherein analyzing the dataset comprises using an artificial intelligence process ([0065], [0068]-[0069], [0110]); wherein the artificial intelligence process outputs at least one of: a current position and orientation of the ultrasound probe relative to the selected view ([0065], [0068]-[0069], [0110]); wherein the conveying comprises generating, based on at least a portion of the dataset, one or more images each comprising one or more visual cues indicating the current position and orientation, and causing a presentation of the one or more images on a display ([0066]-[0067]; [0078]-[0079]); wherein the one or more visual cues comprises at least one of an indication of a type, a direction, and a measure of motion required to bring the probe from its current position and orientation to its target position and orientation ([0066]-[0067]; [0078]-[0079]).
Kezurer fails to show wherein the dataset comprises at least ultrasound image and at least one blood flow information obtained together, said associated blood flow information also providing information about a cardiac cycle timing of said image; which aligns the probe taking said cardiac cycle into account. Also, wherein the at least one dataset obtained during a pulsed Doppler mode operation of the probe comprises an image and Doppler information; wherein the image is augmented with the Doppler information; wherein the analyzing comprises analyzing a motion within the body part based on pulsed Doppler mode information; wherein the motion is a motion of fluid within the body part.
Kezurer fails to show analyzing said at least one ultrasound image and said at least one blood flow information.
Kezurer fails to show using an artificial intelligence process trained on ultrasound images and blood flow information to take into account a relationship between a temporal degree of freedom within a cardiac cycle of fluid flow and at least one spatial degree of freedom, correctly acquire a selected view of a body part irrespective of whether or not a heart is in said selected view.
Kezurer fails to show wherein the conveying comprises presenting an image quality indication scale on a display.
Takeuchi discloses guidance information for an ultrasonic diagnostic probe. Takeuchi teaches wherein the dataset comprises at least ultrasound image and at least one blood flow information obtained together, said associated blood flow information also providing information about a cardiac cycle timing of said image ([0036]); which aligns the probe taking said cardiac cycle into account (the provided Doppler information is considered to take the cardiac cycle into account as Doppler information is representative of the blood flow and related cardiac cycle timing of the patient; [0060]-[0061], Fig. 7A). Also, wherein the at least one dataset obtained during a pulsed Doppler mode operation of the probe comprises an image and Doppler information ([0036]; wherein the image is augmented with the Doppler information ([0036]); wherein the analyzing comprises analyzing a motion within the body part based on pulsed Doppler mode information ([0036]); wherein the motion is a motion of fluid within the body part ([0036]).
Mochizuki discloses an ultrasound diagnostic apparatus. Mochizuki teaches analyzing said at least one ultrasound image and said at least one blood flow information (calculate distance between blood vessel and body surface by analyzing the Doppler data and the B-mode data in combination; [0048], [0075]).
Sasaki discloses ultrasound diagnostic apparatus and methods. Sasaki teaches using an artificial intelligence process trained on ultrasound images and blood flow information to take into account a relationship between a temporal degree of freedom within a cardiac cycle of fluid flow and at least one spatial degree of freedom, correctly acquire a selected view of a body part irrespective of whether or not a heart is in said selected view (regardless of the type of blood vessel drawn in the ultrasonic image; [0055]-[0056], [0062]-[0063]).
Cadieu discloses displays for ultrasound diagnostics. Cadieu teaches wherein the conveying comprises presenting an image quality indication scale on a display ([0022]).
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 invention of Kezurer to utilize Doppler information which provides cardiac cycle timing information as taught by Takeuchi, as the benefits of Doppler type data in the field of medical ultrasound diagnostics are known in the art, and in particular Doppler type imaging will obtain information regarding moving particles, such that blood flow information may be accurately determined and conveyed to the user in the images.
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 combined invention of Kezurer and Takeuchi to analyze the combination of the B-mode and Doppler data as taught by Mochizuki, as analyzing the B-mode and Doppler data in combination provides the complementary information from each of the modalities, where B-mode is particularly beneficial for analyzing structures within the image and where Doppler is particularly beneficial for analyzing blood flow, and where the benefits of each may be advantageously provided to the user.
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 combined invention of Kezurer, Takeuchi, and Mochizuki to utilize artificial intelligence methods trained on ultrasound images and blood flow information as taught by Sasaki, in order to provide an computer based technique which combines the obtained diagnostic information corresponding with B-mode ultrasound images and Doppler blood flow information in order to automatically produce a more accurate final displayed result by combining the complementary information in an automated machine learning technique.
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 combined invention of Kezurer, Takeuchi, Mochizuki, and Sasaki to display an image quality indication as taught by Cadieu, as this will aid in alerting the user when a poor image is obtained so that the user may be guided to obtain a higher quality image.
Further, it should be noted that Kezurer recognizes that any suitable display or interface may be used to convey the information to the user (Kezurer, [0079]), and thus the use of different types of displays or user interfaces for the guidance information as described above would be an obvious modification to one of ordinary skill in the art.
Response to Arguments
Applicant's arguments filed 11/12/25 have been fully considered but they are not persuasive.
In response to applicant’s arguments regarding the limitation “said associated blood flow information also providing information about cardiac cycle timing of said image”, the examiner notes that Takeuchi teaches using a combined B-mode and Doppler display format to aid in guiding the user to correctly align the probe ([0036], [0060]-[0061]; Fig. 7A). The Doppler information is considered to provide information about cardiac cycle timing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN CWERN/ Primary Examiner, Art Unit 3797