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
This action is in response to the remarks filed on 12/8/2025.
The amendments filed on 12/8/2025 have been entered. Accordingly claims 1-2, 4-21 remain pending. Claim 3 is cancelled. Claims 10-21 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group of inventions II and III. Claims 1-2 and 4-9 are examined on their merits.
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 1-2 and 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Davidsen (US20180168544A1) in view of Mo et al (US 20070078345 A1).
Regarding claim 1, Davidsen teaches an ultrasound system (see figs. 1 and 7 as well as the associated pars.), comprising:
a transducer array (e.g., flexible transducer 14), comprising:
a flexible substrate (“flexible array 200 illustrated in FIG. 2A may include multiple transducer elements (not shown) coupled to and/or embedded in a flexible substrate.” [0022]);
ultrasound transducer elements disposed on the flexible substrate (“flexible array 200 illustrated in FIG. 2A may include multiple transducer elements (not shown) coupled to and/or embedded in a flexible substrate.” [0022]) and configured to transmit and acquire ultrasound signals that propagate in a body of a patient (“FIG. 1, an ultrasound probe 12 includes a transducer array 14 for transmitting ultrasonic waves and receiving echo information” [0017]); and
strain sensors coupled to or integrated into the flexible substrate (“The data from the strain sensors may be used by the ultrasound imaging system 10 to determine the position and orientation of the flexible array and the individual transducer elements. For example, as described above, the piecewise flexible array 205 may include multiple rigid sub-arrays 220, each with one or more transducer elements. The piecewise flexible array 205 may include strain sensors 215 between each rigid sub-array 220.” [0026]) and configured to measure a strain in the flexible substrate generated by flexing the flexible substrate (“the strain sensors 215 may allow an ultrasound imaging system 10 to determine the position and orientation of the sub-arrays 220 to one another for beamforming and/or other purposes.” [0026]); and
a processor (e.g. image processor 36, graphics processor 36, signal processor 26) coupled to the ultrasound transducer elements and the strain sensors (see figs. 1, 2, 4 and the associated pars.), wherein the processor is configured to process the signals acquired by the ultrasound transducer elements based at least in part on the strain measured by the strain sensors (e.g. image processor 36 for further enhancement, buffering and temporary storage for display on an image display 38. The graphics processor 36 can generate graphic overlays for display with the ultrasound images.),
and wherein the processor is configured to calculate positions of the ultrasound transducer elements relative to one another based at least in part on the strain (“The strain sensors may detect the magnitude and direction of flex of different portions of the flexible array…data from the strain sensors may be used by the ultrasound imaging system 10 to determine the position and orientation of the flexible array and the individual transducer elements” [0026]), and wherein the processor is configured to continuously modify transmission and reception time-delay parameters based at least in part on the calculated positions (“main beamformer 22 may control transmission and reception of signals by the transducer elements in the transducer array 14” [0017]).
As clearly can be seen above, Davidsen teaches all the limitations of the claim. Yet, in order to provide compact prosecution, if one argues in a different interpretation of the claims, Mo reference is brought in to show the teachings in “narrower” interpretations.
Mo, in the same field of endeavor, also teaches transducer array includes two or more sub-arrays that move relative to each other. Position sensors on each of the sub-arrays provide spatial coordination for beamforming and/or image forming to yield extended field of view and high image resolution. The adaptable transducer array, such as mounted on a flexible transducer housing, allows the array to better conform to the patient during internal or external use (abst). The surface of the array, such as joints or areas between sub-arrays, is bendable [stretchable] to fit a body contour. For example, bending occurs between the rigid sub-arrays. Each sub-array has a position sensor for beam forming and/or imaging reconstruction [0017]. The transducer housing 12 is a flexible substrate, such as a sheet of Kapton polyimide film or a thin flexible PWB that is bendable [0023]. The position sensors 20 are relative or absolute position sensors. Relative position sensors include strain gauges or other sensors for determining position relative to another object or location of the sensor [0031]. The relative delays or phasing between channels is a function of the positions of the channels. Since elements 18 for different sub-arrays 16 may have different positions based on the relative position of the sub-arrays 16, the locations from the position sensors 20 of the sub-arrays 16 determine, in part, the relative delays or phasing [0035].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with calculate positions of the transducers relative to one another and modify transmission and reception time-delay parameters as taught by Mo because in applications where large field view and high resolution are desired, a large active imaging aperture is desired making feature positions on the generated image accurate ([0003] of Mo).
Regarding claim 2, Davidsen teaches wherein the strain sensors are configured to measure a stretch, a stretch direction, or both (“The strain sensors may detect the magnitude and direction of flex of different portions of the flexible array” [0026]), and wherein the processor is configured to calculate positions of the ultrasound transducer elements relative to one another based at least in part on, the stretch, the stretch direction, or a combination thereof (“data from the strain sensors may be used by the ultrasound imaging system 10 to determine the position and orientation of the flexible array and the individual transducer elements.” [0026]).
Mo also teaches The surface of the array, such as joints or areas between sub-arrays, is bendable [stretchable] to fit a body contour. For example, bending occurs between the rigid sub-arrays. Each sub-array has a position sensor for beam forming and/or imaging reconstruction [0017]. The sub-arrays 16 change position relative to each other by flexing or bending of the transducer housing 12. By allowing the sub-arrays 16 to move relative to each other, the surface of the transducer array 14 is flexible or adapts to a contour [0019]. The transducer housing 12 is a flexible substrate, such as a sheet of Kapton polyimide film or a thin flexible PWB that is bendable [0023]. The position sensors 20 are relative or absolute position sensors. Relative position sensors include strain gauges or other sensors for determining position relative to another object or location of the sensor [0031]. The relative delays or phasing between channels is a function of the positions of the channels. Since elements 18 for different sub-arrays 16 may have different positions based on the relative position of the sub-arrays 16, the locations from the position sensors 20 of the sub-arrays 16 determine, in part, the relative delays or phasing [0035].
Regarding claim 4, Davidsen teaches wherein the processor is configured to construct an image based on the ultrasound signals, and wherein the image represents one or more of lungs, body fluid, cardiac imaging, hear rate, respiration rate, gastrointestinal organs, or brain development (“an ultrasound imaging system 10 constructed in accordance with the principles of the present invention is shown in block diagram form. The ultrasound imaging system 10 may be used to implement the ultrasound imaging system described in the previous example. In the ultrasonic diagnostic imaging system” [0017]; “monitor fetal heartbeat over time.” [0041]).
Regarding claim 5, Davidsen teaches wherein the strain sensors are disposed on the flexible substrate (“The piecewise flexible array 205 may include strain sensors 215 between each rigid sub-array 220.” [0026]).
Regarding claim 6, Davidsen teaches wherein the strain sensors are interspersed with the ultrasound transducer elements on the flexible substrate (“The piecewise flexible array 205 may include strain sensors 215 between each rigid sub-array 220.” [0026]).
Regarding claim 7, Davidsen teaches wherein the transducer array is configured to be coupled to a clothing garment that is worn by the patient (“A transducer positioning device may be used to maintain the force against and/or the position of the flexible transducer array. The device may include an inflatable bladder and a strap…flexible transducer array to the victim then place the inflatable bladder across the distal surface of the flexible transducer array. The EMT may then secure a strap around the patient” [0031]; “The transducer positioning device 450 may include a bladder 405 and a strap 410. In some embodiments, the bladder 405 is coupled to the strap 410. For example, the strap 410 may include two pieces of fabric sewn together, and the bladder 405 may be sewn in between the two pieces of fabric” [0032]; “transducer array may be applied to a maternity patient's abdomen to monitor fetal heartbeat over time” [0041]).
It would have been obvious to an ordinary skilled in the art before the invention was made to have the strap garment having transducer arrays of Davidsen be worn by an infant as it merely requires an ordinary skilled to change size or use the very same device on an infant patient as the courts held that a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
Regarding claim 8, Davidsen teaches wherein the transducer array is coupled to a wearable band configured to be secured to an abdomen of a patient, wherein the patient is a pregnant mother, and wherein the transducer array is configured to detect a heart rate of one or more fetuses in the pregnant mother, a heart rate of the mother, uterine activity within the pregnant mother, fetal movement, fetal position and descent, or a combination thereof (“transducer array may be applied to a maternity patient's abdomen to monitor fetal heartbeat over time” [0041]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Davidsen in view of Mo and further in view of Hamelmann et al (WO2021089364A1 the citations below are from the equivalent of US20230255594A1)
Regarding claim 9, the combination noted above teaches all the claimed limitation except for continuously transmitting signals to the processor.
However, in the same field of endeavor, Hamelmann teaches flexible multi-element ultrasound transducer array T can be wrapped around the maternal abdomen and has the potential to monitor the fetal heart rate continuously for various fetal heart locations, and the possibility of monitoring twins or triplets [0014].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with continuously transmitting signals to the processor as taught by Hamelmann because it would help to provide an improved ultrasound transducer array. ([0005] of Hamelmann).
Response to Arguments
Applicant’s arguments 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 SERKAN AKAR whose telephone number is (571)270-5338. The examiner can normally be reached 9am-5pm M-F.
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, 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.
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.
/SERKAN AKAR/ Primary Examiner, Art Unit 3797