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
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 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.
Claim(s) 1, 8-11, 18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smistad et al. (US 2022/0304653 A1, Sep. 29, 2022) (hereinafter “Smistad”).
Regarding claims 1, 11 and 20: Smistad discloses a system and method comprising: an ultrasound probe ([0062]); a display ([0092] - a graphical user interface/visual display that provides feedback to the user implicitly discloses a display); a memory configured to store instructions ([0055]); and one or more processors ([0063]) configured to: control the ultrasound probe to acquire three-dimensional (3D) ultrasound data of an optic nerve sheath ([0081], where the acquired data includes 3D data - [0012], [0014]); generate (obtain) at least one line representing a 3D path of an optic nerve that identifies a position and a longitudinal curvature of the optic nerve, based on the 3D ultrasound data ([0083], centre-line 10 of the ONS which "extends along the length of the ONS 2 and/or the optic nerve."; compare figs. 2-3 to instant fig. 12 C); control the display to display a preview ultrasound image that is a curved plane image that follows a 3D path of an optic nerve based on the position and a longitudinal curvature of the optic nerve ([0093]-[0094]; figs. 5-6 – the image that is displayed during the probe guidance process is considered a “preview image” and the image shows a “curved plane” of the optic nerve – an image without any portions of the curve being cut off or going out of frame - as depicted graphically in at least figs. 2-3); determine a measurement position along the 3D path of the optic nerve that is located a predetermined distance from an anatomical structure along the 3D path ([0087]-[0088], [0092], fig. 4); determine one or more measurement planes that are planar with a centerline of the optic nerve or that are orthogonal to the centerline of the optic nerve ([0087]-[0088], the plane marked as "Area A", figs. 5-6); determine a measurement of the optic nerve sheath based on the 3D ultrasound data at the measurement position in one or more measurement planes ([0030]-[0035], [0088]-[0090]); and control the display to display information related to the measurement of the optic nerve sheath (figs. 5-6).
Regarding claim 8: Smistad discloses the ultrasound imaging system of claim 1, wherein the information related to the measurement of the optic nerve sheath includes the measurement of the optic nerve sheath ([0030]-[0035], [0088]-[0090], figs. 5-6).
Regarding claim 9: Smistad discloses the ultrasound imaging system of claim 1, wherein the generating the at least one line comprises one or more of region growth segmentation and eigen analysis ([0083]).
Regarding claim 18: Smistad discloses the method of claim 11, wherein the information related to the measurement of the optic nerve sheath includes the measurement of the optic nerve sheath ([0030]-[0035], [0088]-[0090], figs. 5-6).
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.
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.
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) 2-3 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smistad in view of Negishi (US 2020/0359993 A1, Nov. 19, 2020) (hereinafter “Negishi”).
Regarding claims 2 and 12: Smistad discloses acquiring positioning ultrasound data (at least image 18) and displaying guidance information to the operator to position the probe with respect to the optic nerve sheath (figs. 5-6 [0093]-[0099]), but silent on a scan quality metric.
Negishi, in the same field of endeavor, teaches a system and method for measuring the optic nerve sheath comprising a processor configured to control/controlling an ultrasound probe to acquire positioning ultrasound data ([0054], step S1 - the acquired ultrasound image is used for determining whether the probe is properly positioned which makes it "positioning ultrasound data"); determining a scan quality metric associated with the optic nerve sheath based on the positioning ultrasound data ([0057-[0058], slope threshold determined in step S5); and controlling the display to display scan guidance information that guides an operator of the ultrasound probe to position the ultrasound probe with respect to the optic nerve sheath based on the scan quality metric ([0074], fig. 8).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system and method of Smistad by including the quality metric of Negishi, and basing the displayed guidance on the quality metric as taught by Negishi, in order to provide an objective standard for image quality, rather than subjective or user-dependent determinations, which may result in more consistent acquisition.
Regarding claims 3 and 13: Smistad discloses acquiring positioning ultrasound data (at least image 18) and displaying guidance information to the operator to position the probe with respect to the optic nerve sheath (figs. 5-6 [0093]-[0099]), and contemplates a fully or partially automated system for image acquisition based on proper probe alignment ([0016]-[0018]), but silent on a scan quality metric.
Negishi, in the same field of endeavor, teaches a system and method comprising controlling an ultrasound probe to acquire positioning ultrasound data ([0054], step S1 - the acquired ultrasound image is used for determining whether the probe is properly positioned which makes it "positioning ultrasound data"); and determine a scan quality metric associated with the optic nerve sheath based on the positioning ultrasound data ([0057-[0058], slope threshold determined in step S5). Negishi further acquires additional image data based on the result of the scan quality metric (either re-acquiring the positioning data or acquiring additional image data for measurement in step S9 - [0062], fig. 5).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system and method of Smistad by including the quality metric of Negishi, and basing the displayed guidance on the quality metric as taught by Negishi, in order to provide an objective standard for image quality, rather than subjective or user-dependent determinations, which may result in more consistent acquisition.
While Smistad and Negishi do not explicitly describe automatic acquisition, Smistad contemplates a fully automated system which “could be implemented via devices that do not require any manual input for handling of the probe” ([0016]). Moreover, in the absence of any evidence of criticality or unexpected result, it is considered to have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to include automatic acquisition since it has been held by the courts that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art, as it requires only ordinary skill in the art. In re Venner, 120 USPQ 192 (CCPA 1958).
Claim(s) 4 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smistad in view of Sasaki (US 2009/0054776 A1, Feb. 26, 2009) (hereinafter “Sasaki”).
Regarding claims 4 and 14: Smistad discloses the system of claim 1 and method of claim 11, including controlling the ultrasound probe to acquire positioning ultrasound data (at least image 18); and control the display to display a preview ultrasound image that follows a 3D path of an optic nerve based on the positioning ultrasound data (figs. 5-6 – the image that is displayed during the probe guidance process is considered a “preview image”), but does not teach that the image is a bi-plane ultrasound image or a multi-plane ultrasound image, in real-time with respect to the acquiring of the positioning ultrasound data.
Sasaki, in the same problem solving area of ultrasound imaging, teaches a system and method comprising acquiring preliminary images and displaying a preview ultrasound image, that is a bi-plane ultrasound image or a multi-plane ultrasound image, in real-time with respect to the acquiring of the preliminary ultrasound data (fig. 9, [0061], [0110]-[0111] - steps S2 and S3, preview image displayed to verify proper imaging conditions, including appropriate positioning of the probe, prior to 3D acquisition).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system and method of Smistad by displaying the positioning ultrasound data in order to save time and increase efficiency by allowing the user to verify proper imaging conditions prior to acquisition of the entire 3D data set.
Claim(s) 6-7 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smistad in view of Lyon (US 2016/0000367 A1, Jan. 7, 2016) (hereinafter “Lyon”).
Regarding claims 6 and 16: Smistad discloses the system of claim 1 and method of claim 11, including providing a displayed image (at least figs. 5-6). However, Smistad is silent on three-dimensionally segmenting the optic nerve sheath based on the 3D ultrasound data; and controlling the display to display the three-dimensionally segmented optic nerve sheath in a long-axis plane.
Lyon, in the same field of endeavor, teaches 3D ultrasound acquisition of the optic nerve sheath including three-dimensionally segmenting the optic nerve sheath based on the 3D ultrasound data ([0050]); and controlling the display to display the three-dimensionally segmented optic nerve sheath in a long-axis plane ([0056], figs. 13-15). Lyon further teaches that the 3D shape of the ONS can be used to detect subtle changes in the intercranial pressure (ICP) and that the ability to visualize subtle changes in the surface structure can aid diagnosis ([0049]-[0051]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system and method of Smistad by providing the segmented 3D images of Lyon in order to provide the user with additional diagnostic information based on surface changes of the ONS in view of the further teachings of Lyon.
Regarding claim 7: Smistad discloses the system of claim 1, including providing a displayed image (at least figs. 5-6). However, Smistad is silent on three-dimensionally segmenting the optic nerve sheath based on the 3D ultrasound data; and controlling the display to display the three-dimensionally segmented optic nerve sheath in a short-axis plane.
Lyon, in the same field of endeavor, teaches 3D ultrasound acquisition of the optic nerve sheath including three-dimensionally segmenting the optic nerve sheath based on the 3D ultrasound data ([0050]); and controlling the display to display the three-dimensionally segmented optic nerve sheath in a short-axis plane ([0056], figs. 14-15). Lyon further teaches that the 3D shape of the ONS can be used to detect subtle changes in the intercranial pressure (ICP) and that the ability to visualize subtle changes in the surface structure can aid diagnosis ([0049]-[0051]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system and method of Quirk by providing the segmented 3D images of Lyon in order to provide the user with additional diagnostic information based on surface changes of the ONS in view of the further teachings of Lyon.
Regarding claim 17: Smistad discloses the method of claim 11, including providing a displayed image (at least figs. 5-6). However, Smistad is silent on wherein the determining one or more measurement planes comprises determining a first measurement plane corresponding to a short axis view of the ultrasound probe or a transverse plane and a second measurement plane corresponding to a long axis view of the ultrasound probe or a transverse plane.
Lyon, in the same field of endeavor, teaches determining a first measurement plane corresponding to a short axis view of the ultrasound probe or a transverse plane and a second measurement plane corresponding to a long axis view of the ultrasound probe or a transverse plane ([0056], figs. 14-15). Lyon further teaches that the 3D shape (the shape in more than one plane) of the ONS can be used to detect subtle changes in the intercranial pressure (ICP) and that the ability to visualize subtle changes in the surface structure can aid diagnosis ([0049]-[0051]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system and method of Smistad by providing the multiple planes of Lyon in order to provide the user with additional diagnostic information based on surface changes of the ONS in view of the further teachings of Lyon.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smistad in view of Soroushmehr et al. (US 2021/0022631 A1, Jan. 28, 2021) (hereinafter “Soroushmehr”).
Regarding claims 19: Smistad discloses the method of claim 11, but is silent on wherein the information related to the measurement of the optic nerve sheath includes an indicator in a change in a size of the optic nerve sheath.
Soroushmehr, in the same field of endeavor, teaches obtaining an indicator in a change in a size of the optic nerve sheath ([0007], [0057], [0058]). Soroushmehr further teaches that the diameter of the optic nerve sheath changes rapidly with changes in CSF pressure ([0007]) and acquiring repeated measurements to detect changes in the ONS diameter ([0058]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system and method of Smistad by providing an indication of a change in a size of the optic nerve sheath as taught by Soroushmehr in order to monitor the patient’s condition over time.
Response to Arguments
Previous rejections of claim 10 under 35 U.S.C. §112(a) and (b) are withdrawn in light of the cancelation of claim 10.
Applicant’s arguments with respect to amended claims 1, 11, and 20 have been fully considered but are moot in view of the updated grounds of rejection necessitated by amendment. However, in the interest of advancing prosecution certain of Applicant’s arguments will be addressed.
Applicant argues that support for “a curved plane image” is found in instant paragraph [0074]. Examiner notes that this limitation has previously been subject to rejection under 35 U.S.C. §112(b). Applicant specifically identifies a portion of instant paragraph [0074] as being a description of a “curved plane image” – “display a preview ultrasound image that in follows a 3D path of an optic nerve…. by controlling the display 118 to display the ultrasound preview image corresponding to the curved plane, the processor 116 may facilitate the acquisition of more accurate ultrasound images for determining the measurement of the optic nerve sheath.” This description appears to correspond to an image that simply shows the entirety of the curved portion of the ONS. However Applicant’s additional description of “…a displayed plane may be curved to follow a path of the optic. A person of ordinary skill in the art would certainly understand how to obtain an image of a plane curved to follow the curvature and position of the optic nerve from a 3D volume.” This description is less clear and appears to indicate that the image itself (or possibly the plane?) is somehow curved. This also does not appear to entirely correspond to what is in the disclosure. In the interest of advancing prosecution, Examiner will adopt the interpretation of “curved plane image” that corresponds to the description of an image that shows the entirety of the curved portion of the ONS (without any part of the curve being cut off or going out of frame) as set forth in paragraph [0074]. Examiner further notes that it may be helpful for Applicant to identify which of the instant figures depicts a “curved plane image” to provide Examiner of a better understanding of the claimed image.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Koharski can be reached on (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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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799