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 .
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 21, 23, 26-31, 33, and 37-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 9-15, and 17-20 of copending Application No. 17715128 (reference application) in view of Huepf et al. (US 2020/0113544; hereinafter Huepf). 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 instant invention, the claim differs from claim 1 of the reference application 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 reference application. Furthermore, regarding the specific shape of the visual cues described in claims 21 and 31 of the instant 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.
Furthermore, regarding the limitation “a visual marker whose position near said cross figure corresponds to a position of a physical marker on a probe”, this feature is taught by Huepf ([0039]-[0041]; Figs. 2-10). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, 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 21, 23, 26-31, 33, and 37-40 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), Huepf et al. (US 2020/0113544; hereinafter Huepf), and Cadieu et al. (US 2021/0052253; hereinafter Cadieu).
Kezurer shows a method and system for positioning and orienting of an ultrasound probe (abstract), the system comprising: a computer processor; and one or more sets of instructions which, when executed, cause the computer processor to: receive or determine a dataset indicating a type, a direction and a measure of motion required to bring an ultrasound probe from its current position and orientation to its target position and orientation, wherein the target position and orientation align the ultrasound probe to correctly acquire a selected view of a body part ([0066]-[0067]; [0078]-[0079]); generate, based on at least a portion of the dataset, one or more images each comprising one or more visual cues indicating the type, the direction and the measure of motion required to bring the ultrasound probe from its current position and orientation its target position and orientation; and cause a presentation of the one or more images on a display ([0066]-[0067]; [0078]-[0079]); wherein each of the one or more images comprises: a first visual cue indicating the target position and orientation of the ultrasound probe ([0078]-[0079]); and a second visual cue indicating the current position and orientation of the ultrasound probe relative to the target position and orientation of the ultrasound probe ([0078]-[0079]);
Also, wherein the one or more sets of instructions, when executed, cause the computer processor further to: receive at least one ultrasound image acquired by the ultrasound probe in the current position and orientation thereof ([0066]); and feed the at least one ultrasound image and the selected view of the body part as an input into a neural network, wherein the neural network being implemented on the computer processor and configured to output the dataset ([0065], [0068]-[0069], [0110]); wherein analyzing the image comprises using an artificial intelligence process ([0065], [0068]-[0069], [0110]).
Kezurer further shows a relative position and orientation between the second visual cue and the first visual cue are indicating the type and the direction of motion required to bring the ultrasound probe from its current position and orientation to its target position and orientation ([0078]-[0079]). Kezurer further shows wherein the second visual cue comprises an arrow ([0067]).
Kezurer fails to show a distance between a specified point on the second visual cue and a corresponding specified point on the first visual cue is indicating the measure of motion required to bring the ultrasound probe from its current position and orientation to its target position and orientation; wherein the first visual cue comprising: 15P-601791-US a cross figure having two bars which are perpendicular to each other and intersecting at an intersection point; wherein the cross figure represents a proximal end of the ultrasound probe in its target position and orientation; wherein the intersection point represents a central longitudinal axis of the ultrasound probe in its target position and orientation; and wherein a plane defined by the bars represents a plane that is perpendicular to the central longitudinal axis of the ultrasound probe its target position and orientation; wherein the first visual cue further comprises a visual marker which position corresponds to a position of a corresponding physical marker on the ultrasound probe; wherein the second visual cue comprising: a 2D projection of a 3D representation of the ultrasound probe in its current position and orientation; and a second cross figure having two second bars which are perpendicular to each other and intersecting at a second intersection point; wherein the second cross figure represents the proximal end of the ultrasound probe in its current position and orientation; wherein the second intersection point represents the central longitudinal axis of the ultrasound probe in its current position and orientation; and wherein a plane defined by the second bars represents a plane that is perpendicular to the central longitudinal axis of the ultrasound probe its current position and orientation; wherein the second visual cue further comprises a second visual marker which position corresponds to a position of a corresponding physical marker on the ultrasound probe; wherein the second visual cue comprises an arrow, wherein a shape of the arrow indicates the type of motion, a direction of the arrow indicates the direction of 16P-601791-US motion and a size of the arrow indicates the measure of motion required to bring the ultrasound probe from its current position and orientation to its target position and orientation; wherein the second visual cue comprises a text indicator having numeral values to quantify the measure of motion required to bring the ultrasound probe from its current position and orientation to its target position and orientation; wherein the first visual cue comprises a visual representation of at least a portion of the subject body.
Kezurer fails to show an ultrasound probe having a physical marker thereon on one lateral side thereof; and a visual marker at one end of one of said two bars whose position corresponds to a position of a physical marker on said probe.
Kezurer fails to show receive or determine an image quality indication indicating a quality of a received ultrasound image produced by the ultrasound probe at its current position and orientation as being of the selected view; generate, based on said image quality indication, an image quality indication scale indicating said quality of the received ultrasound image as being of the selected view; cause a presentation of the one or more images and the image quality indication scale on a display.
Takeuchi discloses guidance information for an ultrasonic diagnostic probe. Takeuchi teaches wherein the first visual cue further comprises a visual marker which position corresponds to a position of a corresponding physical marker on the ultrasound probe (probe information 46 is considered a visual marker which corresponds to the real position of the physical markings of the ultrasound probe; Figure 7A); wherein the second visual cue comprising: a 2D projection of a 3D representation of the ultrasound probe in its current position and orientation; and a second cross figure having two second bars which are perpendicular to each other and intersecting at a second intersection point; wherein the second cross figure represents the proximal end of the ultrasound probe in its current position and orientation; wherein the second intersection point represents the central longitudinal axis of the ultrasound probe in its current position and orientation; and wherein a plane defined by the second bars represents a plane that is perpendicular to the central longitudinal axis of the ultrasound probe its current position and orientation (probe movement information 46 which illustrates a view of the physical probe in its current position and in its desired target position, including intersecting perpendicular lines defining the plane of the probe, Figure 7A); wherein the second visual cue further comprises a second visual marker which position corresponds to a position of a corresponding physical marker on the ultrasound probe (probe information 46 is considered a visual marker which corresponds to the real position of the physical markings of the ultrasound probe; Figure 7A).
Takeuchi also teaches a distance between a specified point on the second visual cue and a corresponding specified point on the first visual cue is indicating the measure of motion required to bring the ultrasound probe from its current position and orientation to its target position and orientation (probe movement information including both direction and quantity of movement, [0048]); wherein the first visual cue comprising: 15P-601791-US a cross figure having two bars which are perpendicular to each other and intersecting at an intersection point; wherein the cross figure represents a proximal end of the ultrasound probe in its target position and orientation; wherein the intersection point represents a central longitudinal axis of the ultrasound probe in its target position and orientation; and wherein a plane defined by the bars represents a plane that is perpendicular to the central longitudinal axis of the ultrasound probe its target position and orientation (probe movement information 46 which illustrates a view of the physical probe in its current position and in its desired target position, including intersecting perpendicular lines defining the plane of the probe, Figure 7A); wherein the second visual cue comprises a text indicator having numeral values to quantify the measure of motion required to bring the ultrasound probe from its current position and orientation to its target position and orientation (display position information 44, [0057]; Figure 7A); wherein the first visual cue comprises a visual representation of at least a portion of the subject body (Figure 7A illustrates the ultrasound image which is a visual representation of the subject body along with the position of the physical ultrasound probe).
Huepf discloses methods and systems for enhanced visualization of ultrasound probe positioning feedback. Huepf teaches an ultrasound probe having a physical marker thereon on one lateral side thereof (position sensing system 112 attached to probe, provides probe position data to generate the reticle 300 corresponding with the probe position and orientation, [0026], [0040], [0058]); and a visual marker at one end of one of said two bars whose position corresponds to a position of a physical marker on said probe (lateral reticle element 304; [0039]-[0041]; Figs. 2-10).
Cadieu discloses systems for ultrasound guidance. Cadieu teaches receive or determine an image quality indication indicating a quality of a received ultrasound image produced by the ultrasound probe at its current position and orientation as being of the selected view ([0022]); generate, based on said image quality indication, an image quality indication scale indicating said quality of the received ultrasound image as being of the selected view ([0022]); cause a presentation of the one or more images and the 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 a graphical display which illustrates the probe in its current and desired position by utilizing a cross figure as taught by Takeuchi, as this type of display format will allow the user to more quickly understand the position of the probe and the manner in which the user must move it to properly align the probe in the desired position.
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 a distance to indicate the measure of motion required to bring the probe from its current to its target position as taught by Takeuchi, as this will provide additional guidance information to the user, allowing the user to more accurately guide the ultrasound probe.
Furthermore, as Kezurer utilizes arrows to indicate directions of movement to guide the probe, in the combined invention with Takeuchi which also provides the user with the quantity of movement required 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 invention of Kezurer to utilize arrows which indicate directions of movement and also which indicate quantity of movement, as this will provide both types of probe movement information (direction and quantity) in a single easy to view format.
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 text information as taught by Takeuchi, as this will provide the user with an additional display format to more readily determine the location of the probe and the manner in which it should be moved to reach the desired position.
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.
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 provide an additional diagnostic display such as a visual marker at one end of said two bars whose position corresponds to a position of a physical marker on a probe as taught by Huepf, as Huepf teaches that this type of visual marker will aid the user in aligning the probe into the desired imaging arrangement, by defining the appropriate position, rotation, and tilt of the probe as described by Huepf ([0018]).
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 Huepf to display a quality indication scale as taught by Cadieu, in order to provide the user with an improved visual indication regarding the quality of the obtained diagnostic values in order to guide the ultrasound probe to be positioned according to a desired viewpoint (Cadieu, [0006]-[0008], [0021]).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 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
