DETAILED ACTION
This Office action is responsive to communications filed on 04/23/2026. Claims 7-12, & 15-17 are withdrawn. Presently, Claims 1-6, 13-14 & 18-20 are rejected. Claims 1-20 remain pending.
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 .
Election/Restrictions
Applicant’s election without traverse of Group A, claims 1-6, 13-14 & 18-20 in the reply filed on 10/30/2025 is acknowledged. Claims 1-20 remain pending. Claims 7-12, & 15-17 are withdrawn. Claims 1-6, 13-14 & 18-20 are rejected.
Specification
The disclosure is objected to because of the following informalities and should recite the brief description of FIG. 5. Paragraphs ¶0021-0033 present brief descriptions of the Drawings but omits FIG. 5 brief description entirely.
Claim Objections
The following claims are objected to because of the following informalities and should recite:
Claim 1: “the interface system”
Claim 20: line 3, “without compromising the sterile environment.”.
Appropriate correction is needed.
Claim Rejections - 35 USC § 112
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 1-6, 13-14 & 18-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Claim 1:
“the lumen” in line 8, 10, 12, and throughout the dependent claims 3-4 versus the phrase, “the lumen wall”. There is insufficient antecedent basis for this limitation “the lumen” in the claim, as required by MPEP 2173.05(e). The phrase is unclear. The specification consistently interchanges between lumen vs lumen wall. It is unclear if the phrase is intended to recite the lumen wall or a lumen. Because the shorthanded recitation of “the lumen” would be considered the opening inside the vessel, the transducer would be inside that space so measuring a distance to the lumen in a geometrical sense is unclear. For examination purposes, the Examiner assumes the lumen wall. Accordingly, proper antecedent basis is required. The above rejections to claim 1 apply to claim 13 for substantially identical claim limitations recited in the claim. Appropriate correction is required.
Claim 18:
“the computer” line 1. It is unclear if the phrase refers to or is separate from the computer display. For examination purposes, the Examiner assumes the computer display. Consistent claim language is required when referring to the same term. Appropriate correction is required.
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, & 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cohen et al (US 20200029932 A1).
Claim 1: Cohen discloses, An interface system for ultrasound measurements, the system comprising: (¶0031, ¶0033, ¶0039 -intraluminal imaging system 100, IVUS. The system is designed to interface with the patient and process data including a PIM 104 that transfers received echo signals to processing system 106.)
a computer display (display device or computer monitor 108) configured for displaying the ultrasound measurements; (108 is configured to display automatic ultrasound measurements such as vessel boundary area, lumen diameter, and minimum lumen area (MLA), ¶0031, ¶0045, ¶0056, Claim 1.) and
one or more processors (processing system 106) programmed and configured to: (¶0039, ¶0042)
receive sets of ultrasound signals through a plurality of transducers of an ultrasound probe proximate to a lumen wall; (¶0031, ¶0037, the probe 102 is arranged to be positioned within a body lumen 120 of the patient. It uses scanner assembly 110 mounted near its distal end that includes transducer array 124 (i.e., plurality of ultrasound transducers) to emit ultrasonic energy and receive ultrasound echo signals reflected by the surrounding tissue.)
for each received ultrasound signal, calculate a distance between the receiving ultrasound transducer and the lumen; (¶0041, ¶0056, ¶0062, The processing system 106 receives the echo data from the transducer array and processes it to reconstruct an image of the tissue structures in the lumen surrounding the scanner. Using this data, the system performs automatic dimensional and length measurements locating the center of the vessel, vessel boundaries, and measuring vessel diameters. Calculating dimensional boundaries (i.e., the lumen walls) relative to the center of the vessel where the IVUS and transducers are located to map the area and diameter of the vessel directly teaches determining the distance between the receiving transducers and the lumen.)
based on the calculated distances for each set of ultrasound signals, determine a respective shape of a cross-section of the lumen; and (¶0041, ¶0053, ¶0064, using the processed echo signals to output cross-sectional IVUS images (i.e., transverse views) of the lumen. The system also automatically measures and displays the shape and size of the lumen boundary.)
cause the computer display to simultaneously generate a plurality of representations of the lumen indicating differences in size and geometry between the respective shapes. (¶0006-0007, ¶0060, The controller/processing system 106 is configured to display two or more transverse images (i.e., cross-sections) of the body lumen on a single screen. The system also provides side-by-side analysis of these intraluminal images the indicate sizing and geometric differences. ¶0060, it displays a comparison between the border measurements of the first transverse view and a second transverse view using lines and numerical comparison data to show the differences and position of the lumen boarders. See also, ¶0012, ¶0053, ¶0056, ¶0058-0060, ¶0062, ¶0064.)
Claim 2: Cohen discloses all the elements above in claim 1, Cohen discloses, wherein the plurality of representations comprises two or more of the respective shapes overlapping each other from a front-facing perspective. (¶0006, ¶0041, ¶0058-0060, ¶0064.)
Claim 3: Cohen discloses all the elements above in claim 2, Cohen discloses, wherein each respective shape of a cross-section of the lumen represents a different longitudinal position of the lumen. (¶0006-0007, ¶0009, ¶0011-0012, ¶0053, ¶0058-0059, ¶0061)
Claim 4: Cohen discloses all the elements above in claim 2, Cohen discloses, wherein a plurality of the respective shapes of a cross-section of the lumen represent a same longitudinal position of the lumen at different time points. (¶0066, ¶0068-0069, ¶0077)
Claim 5: Cohen discloses all the elements above in claim 4, Cohen discloses, wherein a first time point of the different time points represents a time prior to a lumen-treatment procedure (¶0045, ¶0068-0069, ¶0072) and a second time point of the different time points represents a time after the lumen-treatment procedure (¶0068-0069, ¶0072, ¶0077).
Claim 6: Cohen discloses all the elements above in claim 5, Cohen discloses, wherein the lumen-treatment procedure is at least one of a stent placement (¶0045, ¶0048, ¶0057, ¶0072), angioplasty, or obstruction crossing procedure.
Claim 13: Cohen discloses, A method for generating images of ultrasound measurements, the method comprising: (¶0031, ¶0033, ¶0039 -intraluminal imaging system 100, IVUS. The system is designed to interface with the patient and process data including a PIM 104 that transfers received echo signals to processing system 106. See also, ¶Abstract, ¶0010, Claim 10, ¶0070)
receiving sets of ultrasound signals through a plurality of transducers of an ultrasound probe proximate to a lumen wall; (¶0031, ¶0037, the probe 102 is arranged to be positioned within a body lumen 120 of the patient. It uses scanner assembly 110 mounted near its distal end that includes transducer array 124 (i.e., plurality of ultrasound transducers) to emit ultrasonic energy and receive ultrasound echo signals reflected by the surrounding tissue.)
for each received ultrasound signal, calculating a distance between the receiving ultrasound transducer and the lumen; (¶0041, ¶0056, ¶0062, The processing system 106 receives the echo data from the transducer array and processes it to reconstruct an image of the tissue structures in the lumen surrounding the scanner. Using this data, the system performs automatic dimensional and length measurements locating the center of the vessel, vessel boundaries, and measuring vessel diameters. Calculating dimensional boundaries (i.e., the lumen walls) relative to the center of the vessel where the IVUS and transducers are located to map the area and diameter of the vessel directly teaches determining the distance between the receiving transducers and the lumen.)
based on the calculated distances for each set of ultrasound signals, determining a respective shape of a cross-section of the lumen; and (¶0041, ¶0053, ¶0064, using the processed echo signals to output cross-sectional IVUS images (i.e., transverse views) of the lumen. The system also automatically measures and displays the shape and size of the lumen boundary.)
simultaneously generating in a computer display a plurality of representations of the lumen indicating differences in size and geometry between the respective shapes. (¶0006-0007, ¶0060, The controller/processing system 106 is configured to display two or more transverse images (i.e., cross-sections) of the body lumen on a single screen. The system also provides side-by-side analysis of these intraluminal images the indicate sizing and geometric differences. ¶0060, it displays a comparison between the border measurements of the first transverse view and a second transverse view using lines and numerical comparison data to show the differences and position of the lumen boarders. See also, ¶0012, ¶0053, ¶0056, ¶0058-0060, ¶0062, ¶0064.)
Claim 14: Cohen discloses all the elements above in claim 13, Cohen discloses, wherein image data representing the lumen wall comprises at least one of angiography (¶0035, ¶0062), optical coherence tomography (OCT) (¶0034, ¶0035, ¶0072), or intravascular ultrasound (IVUS) image data (¶0033, ¶0041, ¶0076).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al (US 20200029932 A1), as applied to claim 1, in further view of Chao et al (US 20200129142 A1).
Claim 18: & Claim 19: Cohen discloses all the elements above in claim 13, Cohen fails to disclose:
wherein the computer is configured to recognize a user interaction through gestures and voice commands.
wherein use of the voice commands promote a sterile environment.
However, Chao in the context of intraluminal ultrasound navigation and system and methods discloses:
wherein the computer is configured to recognize a user interaction through gestures and voice commands. (¶0107, “user to select the marking of the start or end of a vasculature segment through voice, gesture, or other touch-free command, such that a non-sterile staff member is not needed to operate a keyboard, mouse, joystick, or other non-sterile input device.”, the computer is programmatically “configured to” recognize both modalities (i.e. gesture and voice))
wherein use of the voice commands promote a sterile environment. (¶0005, ¶0107, ¶0122, To promote a sterile environment the system is configured to implement the voice commands such that that a non-sterile staff member is not needed to operate a keyboard, mouse, joystick, or other non-sterile input device. ¶0122, The vocal commands avoid the need for a non-sterile staff member to push a button on the touchscreen. By eliminating the need for physical interaction with non-sterile input devices by the staff, the use of voice commands directly promotes and maintains the sterile environment.)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the computer display of Cohen to incorporate the teachings of Chao. The motivation to do this yield predictable results such as avoiding the need for a non-sterile staff member to push a button on the touchscreen, as suggested by Chao, ¶0122.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al (US 20200029932 A1) in view of Chao et al (US 20200129142 A1), as applied to claim 19, in further view of Atarot et al (US 20170212723 A1).
Claim 20: Modified Cohen discloses all the elements above in claim 19, Cohen fails to disclose: wherein the voice commands comprise one or more trigger words to allow the user to interact/manipulate the interface systems without breaking the sterile environment.
However, Chao is relied upon above discloses, wherein the voice commands allow the user to interact/manipulate the interface systems without breaking the sterile environment. (¶0005, ¶0107, ¶0122)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the computer display of modified Cohen to incorporate the teachings of Chao. The motivation to do this yield predictable results such as avoiding the need for a non-sterile staff member to push a button on the touchscreen, as suggested by Chao, ¶0122.
Cohen in view of Chao fail to disclose that the voice commands “comprise one or more trigger words”
However, Atarot in the context of vocally activated surgical controls systems discloses: voice commands comprise one or trigger words. (¶0199) Note; Atarot is relied upon to teach voice commands comprise one or more trigger words.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify voice commands of modified Cohen to incorporate the teachings of Atarot. The motivation to do this yield predictable results such as preventing unintended commands as suggested by Atarot, ¶0207-0208.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ryan (US 20150257732 A1) teaches under the broadest reasonable interpretation, An interface system for ultrasound measurements, the system comprising: a computer display configured for displaying the ultrasound measurements; and one or more processors programmed and configured to: receive sets of ultrasound signals through a plurality of transducers of an ultrasound probe proximate to a lumen wall; for each received ultrasound signal, calculate a distance between the receiving ultrasound transducer and the lumen; based on the calculated distances for each set of ultrasound signals, determine a respective shape of a cross-section of the lumen; and cause the computer display to simultaneously generate a plurality of representations of the lumen indicating differences in size and geometry between the respective shapes.
Huennekens et al (US 20070038061 A1) teaches under the broadest reasonable interpretation, An interface system for ultrasound measurements, the system comprising: a computer display configured for displaying the ultrasound measurements; and one or more processors programmed and configured to: receive sets of ultrasound signals through a plurality of transducers of an ultrasound probe proximate to a lumen wall; for each received ultrasound signal, calculate a distance between the receiving ultrasound transducer and the lumen; based on the calculated distances for each set of ultrasound signals, determine a respective shape of a cross-section of the lumen; and cause the computer display to simultaneously generate a plurality of representations of the lumen indicating differences in size and geometry between the respective shapes.
Chao et al (US 20200129158 A1) teaches under the broadest reasonable interpretation, An interface system for ultrasound measurements, the system comprising: a computer display configured for displaying the ultrasound measurements; and one or more processors programmed and configured to: receive sets of ultrasound signals through a plurality of transducers of an ultrasound probe proximate to a lumen wall; for each received ultrasound signal, calculate a distance between the receiving ultrasound transducer and the lumen; based on the calculated distances for each set of ultrasound signals, determine a respective shape of a cross-section of the lumen; and cause the computer display to simultaneously generate a plurality of representations of the lumen indicating differences in size and geometry between the respective shapes.
Ciompi et al (US 20120283569 A1) teaches under the broadest reasonable interpretation, An interface system for ultrasound measurements, the system comprising: a computer display configured for displaying the ultrasound measurements; and one or more processors programmed and configured to: receive sets of ultrasound signals through a plurality of transducers of an ultrasound probe proximate to a lumen wall; for each received ultrasound signal, calculate a distance between the receiving ultrasound transducer and the lumen; based on the calculated distances for each set of ultrasound signals, determine a respective shape of a cross-section of the lumen; and cause the computer display to simultaneously generate a plurality of representations of the lumen indicating differences in size and geometry between the respective shapes.
Winkler Brown et al (US 20240245390 A1) teaches under the broadest reasonable interpretation, An interface system for ultrasound measurements, the system comprising: a computer display configured for displaying the ultrasound measurements; and one or more processors programmed and configured to: receive sets of ultrasound signals through a plurality of transducers of an ultrasound probe proximate to a lumen wall; for each received ultrasound signal, calculate a distance between the receiving ultrasound transducer and the lumen; based on the calculated distances for each set of ultrasound signals, determine a respective shape of a cross-section of the lumen; and cause the computer display to simultaneously generate a plurality of representations of the lumen indicating differences in size and geometry between the respective shapes.
Chao et al (US 20200129142 A1) teaches under the broadest reasonable interpretation, An interface system for ultrasound measurements, the system comprising: a computer display configured for displaying the ultrasound measurements; and one or more processors programmed and configured to: receive sets of ultrasound signals through a plurality of transducers of an ultrasound probe proximate to a lumen wall; for each received ultrasound signal, calculate a distance between the receiving ultrasound transducer and the lumen; based on the calculated distances for each set of ultrasound signals, determine a respective shape of a cross-section of the lumen; and cause the computer display to simultaneously generate a plurality of representations of the lumen indicating differences in size and geometry between the respective shapes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Robinson whose telephone number is (571)272-9019. The examiner can normally be reached M-F 9:00AM-5:00PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
Prosecution Insights