Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claims 14-20 are added, and claims 1-20 remain pending in the application in response to the applicant’s amendments to the rejections previously set forth in the Non-Final Office Action mailed 02/26/2026.
Election/Restrictions
Newly submitted claims 14-20 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Inventions I (claims 1-7) and III (claims 14-20) are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the process as claimed can be practiced by another materially different apparatus such as an ultrasound imaging system without a tracking device associated with the ultrasound housing, and tracking the ultrasound housing via the tracking device as the ultrasound housing scans over a region of interest.
Inventions II (claims 8-13) and III (claims 14-20) are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different design and function. Invention III recites a tracking device associated with the ultrasound housing, and tracking the ultrasound housing via the tracking device as the ultrasound housing scans over a region of interest, while Invention II does not. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 14-20 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive.
For claim 1, the applicant argues “Mougenot's ultrasound data acquired in step 202 is, however, used solely for calculating speed of sound via time-of-flight measurements, not for generating a sonogram in which segmentation occurs.” (see pg. 9, para. 2 of applicant’s remarks), and the examiner disagrees.
Mougenot teaches a medical imaging system is a diagnostic ultrasound system (see para. 0073), and it is inherent and known in the art that a diagnostic ultrasound system generates ultrasound images (sonograms) from ultrasound data. Therefore, the “medical image data” of Mougenot can be ultrasound images (sonograms), thereby segmenting tissues in ultrasound images (sonograms) (Fig. 2, step 204).
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.
Claims 1-5 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Mougenot et al. (US 20130338485 A1, published December19, 2013) in view of Thiemann et al. (US 20080275339 published November 6, 2008), hereinafter referred to as Mougenot and Thiemann, respectively.
Regarding claim 1, and similarly for claim 8, Mougenot teaches a method of calibrating an ultrasound imaging system, the method comprising:
capturing with the ultrasound imaging system ultrasound image data including a first tissue and a second tissue, the ultrasound image data captured based on a predetermined single speed of ultrasound waves through both the first tissue and the second tissue being the same; generating a sonogram based on the ultrasound image data (see para. 0097 "In step 202 ultrasound data is acquired using an ultrasound transmitter and receiver. Data is acquired for at least two paths through the subject." Where generating an ultrasound image based on transmitting a single speed of sound to tissues is inherent and known in the art);
segmenting the first tissue and the second tissue in the sonogram utilizing an image processing unit of the ultrasound imaging system (see para. 0097 "In step 204 the medical image data is segmented into at least two tissue types. The number of paths through the subject should be at least as large as the number of tissue types.");
identifying a first depth of the first tissue and a second depth of the second tissue based on the sonogram utilizing the image processing unit of the ultrasound imaging system (see para. 0097 "In step 206 the distance traveled [depth] in each of the at least two tissue types is determined.");
identifying an actual first speed of ultrasound waves through the first tissue and an actual second speed of ultrasound waves through the second tissue, wherein the actual first speed is different than the actual second speed (see para. 0097 "Instep 208 the speed of ultrasound in each of the at least two tissue types is calculated.").
Mougenot teaches identifying different speeds of sounds through different tissue depths in an image, but does not explicitly teach repositioning pixels of the image based on the identified different speeds of sounds through different tissue depths.
Whereas, Thiemann, in an analogous field of endeavor, teaches generating a calibrated image by repositioning pixels of the sonogram based on the actual first speed of ultrasound waves through the first tissue and the actual second speed of ultrasound waves through the second tissue (see para. 0022 "In this manner, a calibrated spatial distribution of the speed of sound in the body structure is obtained. This spatial distribution may be used to increase the accuracy in scaling ultrasound images."; see para. 0023 "If the different speed of sound corresponding to the different types of body structure is taken into account and then calibrated in accordance with the method described above by measuring the mean speed of sound, it is possible to further increase the accuracy in scaling.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified identifying different speeds of sounds through different tissue depths in an image, as disclosed in Mougenot, by also repositioning pixels of the image (scaling) based on the identified different speeds of sounds through different tissue depths, as disclosed in Thiemann. One of ordinary skill in the art would have been motivated to make this modification in order to obtain more accurate ultrasound images, as taught in Thiemann (see para. 0060).
Furthermore, regarding claim 2, Mougenot further teaches wherein the image processing unit utilizes an algorithm to segment the first tissue and the second tissue in the sonogram (see para. 0097 "In step 204 the medical image data is segmented into at least two tissue types. The number of paths through the subject should be at least as large as the number of tissue types."; see para. 0055 "At least two different types of tissue are identified or segmented in the medical image data. The medical image data may be segmented using standard segmentation algorithms.").
Furthermore, regarding claims 3 and 9, Mougenot further teaches wherein the image processing unit is configured to segment the first tissue and the second tissue based on differences in texture (see para. 0055 "At least two different types of tissue are identified or segmented in the medical image data. The medical image data may be segmented using standard segmentation algorithms." Where texture segmentation is a well-known type of image process in the art).
Furthermore, regarding claims 4 and 10, Mougenot further teaches wherein the segmenting includes identifying the first tissue and the second tissue based on a location of an ultrasound probe housing relative to anatomy (see para. 0055 "The medical image data may be descriptive of the anatomy of a subject. At least two different types of tissue are identified or segmented in the medical image data. The medical image data may be segmented using standard segmentation algorithms. For instance landmarks in the anatomical data of the medical image data may be identified." Where it is inherent and known in the art to identify different tissues and organs in an image (i.e., heart vs bladder) based on the location of the probe on the body (i.e., chest region vs pelvic region), as the medical practitioner necessarily and inevitably takes into account the position of the probe on the body under examination.).
Furthermore, regarding claims 5 and 11, Mougenot further teaches wherein identifying the first depth and the second depth includes measuring the first depth of the first tissue and measuring the second depth of the second tissue on the sonogram (see para. 0097 "In step 206 the distance traveled [depth] in each of the at least two tissue types is determined.").
Claims 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Mougenot in view of Thiemann, as applied to claims 1 and 8 above, and in further view of Hollaender et al. (US 20180161015 A1, published June 14, 2018), from IDS, hereinafter referred to as Hollaender.
Regarding claims 6 and 12, Mougenot in view of Thiemann teaches all of the elements disclosed in claim 1 and 8 above, respectively.
Mougenot in view of Thiemann identifying different depths of different tissues, but does not explicitly teach estimating the first depth and the second depth based on patient parameters.
Whereas, Hollaender, in an analogous field of endeavor, teaches wherein identifying the first depth and the second depth includes estimating the first depth and the second depth based on patient parameters including one or more of age, sex, weight, and body mass index (BMI) (see para. 0048 "The user input module 230 may comprise suitable circuitry that may be operable to enable obtaining or providing input to the ultrasound system 200, for use in operations thereof. For example, the user input module 230 may be used to input patient data..." where it is inherent and known in the art to identify tissues in an ultrasound image based on patient parameters, for the medical practitioner to include relevant knowledge about the patient under examination (in particular about the anatomical and physiological properties) to assess the plausibility of the results of analysis).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified identifying different depths of different tissues, as disclosed in Mougenot in view of Thiemann, by also estimating the first depth and the second depth based on patient parameters, as disclosed in Hollaender. One of ordinary skill in the art would have been motivated to make this modification in order to further increase the accuracy of the calibrated image.
Claims 7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Mougenot in view of Thiemann, as applied to claims 1 and 8 above, and in further view of Moctezumade la Barrera et al. (US 20230301633 A1, published September28, 2023 with a priority date of August 16, 2017), hereinafter referred to as Barrera.
Regarding claims 7 and 13, Mougenot in view of Thiemann teaches all of the elements disclosed in claim 1 and 8 above, respectively.
Mougenot in view of Thiemann teaches generating a calibrated image, but does not explicitly teach calibrating a position of an ultrasound imaging plane of the ultrasound imaging system based on the calibrated image.
Whereas, Barrera, in an analogous field of endeavor, teaches calibrating a position of an ultrasound imaging plane of the ultrasound imaging system based on the calibrated image (Fig. 6; see para. 0043 “the position of the ultrasound device 21 can be tracked by the surgical navigation system 20, for example, by the optical sensors 40 of the localizer 34 sensing the trackers 50 coupled to the ultrasound device 21 spatial and temporal calibration of the ultrasound imaging by determining the relative transformation between the ultrasound device and image coordinates as detected by the ultrasound device (e.g., the coordinates of the segmented bone surface as adjusted for variances in the speed of sound [calibrated image based on actual speeds of sound]).").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified generating a calibrated image, as disclosed in Mougenot in view of Thiemann, by also calibrating a position of an ultrasound imaging plane of the ultrasound imaging system based on the calibrated image, as disclosed in Barrera. One of ordinary skill in the art would have been motivated to make this modification in order to maximize the two-dimensional ultrasound imaging, and optimize over multiple recordings and handle more arbitrary sweep geometries, as taught in Barrera (see para. 0043).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
St. Pierre et al. (US 20220036545 A1, published February 3, 2022) discloses the ultrasound imaging system may be configured for use with the navigation system by a calibration process using a tracking system.
Fichtinger et al. (US 20140121501 A1, published May 1, 2014) discloses continuously acquiring ultrasound images from a calibration phantom as described herein while simultaneously tracking motion of an ultrasound probe.
Southworth et al. (US 20220354462 A1, published November 10, 2022) discloses the processing system uses tissue depth to account for any measurement errors due to variations in the speed of sound through different media. Since ultrasound imaging is based on time-of-travel of ultrasound waves propagating through a medium (e.g., tissue), different tissue depth or density can affect an instrument's intersect point predicted by the processing system. During calibration, the processing system can use a correction factor associated with a specific medium or density to reduce any speed of sound measurement errors.
THIS ACTION IS MADE FINAL. 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 Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.C./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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