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 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 12/05/2025.
Response to Arguments
For claim 1, in remarks filed 03/02/2026, the applicant argues “Locating and measuring the abdominal aorta is not the same as imaging the entire uterus and the cited portions of Padwal, and the reference as a whole, does not teach a system configured for or capable of ultrasound imaging the uterus” (see pg. 6, para. 5 of applicant’s remarks), and the examiner agrees. Therefore, the 102(a) rejection (Padwal) is withdrawn.
However, for claim 1, the applicant argues “Padwal does not regard imaging a target anatomy at predetermined intervals” (see pg. 6, para. 6 of applicant’s remarks), and the examiner disagrees.
The claim recites “operate the transducer array to acquire the scan data of the entire uterus of the maternal patient at predetermined intervals”. The claim does not recite what the predetermined intervals are, only to acquire data at predetermined intervals. Therefore, under broadest reasonable interpretation, Padwal teaches sequentially (“at predetermined intervals”) providing voltage and acquiring data (Fig. 1A-1D; see para 0068 – “For example, control logic in AFE 410 may sequentially provide voltage to each of CMUT transducers 122-1 through 122-5 illustrated in FIGS. 1A-1C. In response to the applied voltage, each transducer 122 may generate an ultrasound signal (block 720).”).
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 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Padwal et al. (US 20210113194A1, published April 22, 2021) in view of Abraham (US 20090036780 A1, published February 5, 2009), hereinafter referred to as Padwal and Abraham, respectively.
Regarding claim 1, Padwal teaches an ultrasound system, comprising:
a flexible substrate configured to be maintained on an abdomen of a maternal patient (Fig. 1A; see para. 0029 "In other implementations, housing 110 may be a flexible belt or strip that supports CMUTs 122and the electronics. Housing 110 may be placed on a patient's abdomen area and optionally taped onto the patient's abdomen to ensure that housing 110 contacts the patient's abdomen along the entire length of housing 110.");
a transducer array disposed on the flexible substrate and configured to acquire scan data, wherein the transducer array comprises a plurality of transducer elements spread across (Fig. 1A, CMUTs 122-1to122-5 as a transducer array disposed on housing 110 (flexible substrate); see para. 0029 "CMUTs122 may be powered to generate ultrasonic images, as described in more detail below."; see para. 0101 "For example, processing described herein may be used to perform uterus imaging...");
a control system comprising at least one hardware controller (Fig. 8, controller 440) and configured to:
operate the transducer array to acquire the scan data of the entire uterus of the maternal patient at predetermined intervals (Fig. 4; see para. 0068 "For example, control logic in AFE 410 may sequentially [predetermined intervals] provide voltage to each of CMUT transducers 122-1 through 122 5 illustrated in FIGS. 1A-1C. The ultrasound signals may be transmitted through the abdominal wall of patient 800 and reach the target of interest (e.g., the abdominal aorta). The ultrasound signals may echo back from the abdominal aorta and body tissue to CMUT system100. Data acquisition unit 430 receives the echo signals and may forward the echo signals to controller 440 (block 730)."); and
generate a uterus image of the entire uterus at the predetermined intervals based on the scan data (see para. 0033 "That is, each section 152 of CMUT system 140 may contact a portion of the patient's abdomen such that CMUT system 140 follows the contour of the patient's abdomen/mid section. This may allow transducers 122 to maintain contact with the patient's skin and obtain high quality images along the entire length of the target of interest..."; see para. 0070 "In each case, controller 440 may receive the echo data and position information and rotate and/or combine the image data to generate ultrasonic images of the abdominal aorta.").
Padwal teaches uterus imaging, but does not explicitly teach where the transducer array is sized to image a uterus.
Whereas, Abraham, in an analogous field of endeavor, teaches wherein the transducer array comprises a plurality of transducer elements spread across a transducer area sized to image an entire uterus of the maternal patient (see para. 0052 – “FIG. 6 provides an exemplary application of a manipulatable transducer array that may be worn by a pregnant female in the abdominal area for remotely monitoring a fetus…”).
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 the transducer array, as disclosed in Padwal, by having the transducer array sized to image an entire uterus, as disclosed in Abraham. One of ordinary skill in the art would have been motivated to make this modification in order to permit remote monitoring of a fetus during pre-birth and birth from a remote work station, saving valuable bed-side space and providing an invaluable supplement to normal fetus monitoring devices, for example, for monitoring fetus heart rate and pressure, as taught in Abraham (see para. 0052).
Furthermore, regarding claim 8, Padwal further teaches wherein the flexible substrate is connected to a stretchable mesh configured to fit around a torso of the maternal patient and maintain the transducer array on the abdomen (see para. 0029 "In other implementations, housing 110 may be a flexible belt...").
Furthermore, regarding claim 9, Padwal further teaches wherein the flexible substrate comprises a patch configured to adhere to the abdomen (see para. 0029 "Housing 110 maybe placed on a patient's abdomen area and optionally taped onto the patient's abdomen to ensure that housing 110 contacts the patient's abdomen along the entire length of housing 110.").
Furthermore, regarding claim 10, Padwal further teaches wherein the transducer array includes a width number of elements distributed across a width of the transducer area and a height number of transducer elements distributed across a height of the transducer area, wherein the width of the transducer area is greater than the height of the transducer area (Fig. 1A, width and height of CMUTs 112 and housing 110 (transducer area)).
Furthermore, regarding claim 11, Padwal further teaches wherein the width of the transducer area is at least 15 cm and the height of the transducer area is at least 5 cm (Fig. 1A, width and height of transducer area to image entire uterus; see para. 0101 "For example, processing described herein may be used to perform uterus imaging...").
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Padwal in view of Abraham, as applied to claim 1 above, and in further view of Z. Vardar et al, "Pelvic ultrasonography of the postpartum uterus in patients presenting to the emergency room with vaginal bleeding and pelvic pain", Ultrasonography, vol. 41, no. 4, pp. 782-795, Oct. 2022, hereinafter referred to as Vardar.
Regarding claim 2, Padwal in view of Abraham teaches all of the elements disclosed in claim 1 above.
Padwal in view of Abraham teaches generating uterus images, but does not explicitly teach identifying postpartum hemorrhage based on uterus images.
Whereas, Vardar, in the same field of endeavor, teaches wherein the control system is further configured to generate a plurality of uterus images of the entire uterus and to identify an indicator of postpartum hemorrhage (PPH) based on the plurality of uterus images (see Fig. 4 "A. Transverse grayscale ultrasonography shows an isoechoic mass (arrows) within the endometrial cavity B. Color Doppler ultrasonography demonstrates small foci of color flow (open arrow) within the mass. The pathology was retained products of conception [PPH].").
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 uterus images, as disclosed in Padwal in view of Abraham, by also identifying postpartum hemorrhage based on uterus images, as disclosed in Vardar. One of ordinary skill in the art would have been motivated to make this modification in order to allow a rapid diagnosis and treatment initiation, and to distinguish between causes of pelvic pain and vaginal bleeding that may be managed conservatively and those requiring emergent intervention, as taught in Vardar (see Abstract).
Furthermore, regarding claim 3, Vardar further teaches wherein the control system is further configured to compare the plurality of uterus images to a baseline image to identify the indicator of PPH (Fig. 1and 3-6, operator can compare a normal postpartum uterus image(Fig. 1)to an image with retained products of conception (Figs. 3-6, types 0-3); or operator compares a uterus image obtained immediately after delivery (baseline) and a uterus image with PPH obtained days or weeks after delivery from the same patient).
Furthermore, regarding claim 4, Vardar further teaches wherein the indicator of PPH is identified based on a change across the plurality of uterus images (Fig. 1 and 3-6, operator can compare a normal postpartum uterus image (Fig. 1) to an image with retained products of conception (Figs. 3-6, types 0-3); or operator compares a uterus image obtained immediately after delivery (baseline) and a uterus image with PPH obtained days or weeks after delivery from the same patient).
Furthermore, regarding claim 5, Vardar further teaches, wherein the indicator of PPH includes identification of at least one of uterine atony, retained placental tissue, Placenta Accreta Spectrum, or presence of an endometritis based on the plurality of uterus images (see Table 1 "Common postpartum complications and symptoms"; Fig. 3-6, retained products of conception (types 0-3); Fig. 7, endometritis).
The motivation for claim 3-5 was shown previously in claim 2.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Padwal in view of Abraham, as applied to claim 1 above, and in further view of Younghouse et al. (US 20200200715 A1, published June 25, 2020), hereinafter referred to as Younghouse.
Regarding claim 6, Padwal in view of Abraham teaches all of the elements disclosed in claim 1 above.
Padwal in view of Abraham teaches sequentially firing transducer elements (see para. 0068 "For example, control logic in AFE 410 may sequentially provide voltage to each of CMUT transducers 122-1 through 122-5 illustrated in FIGS. 1A-1C."), but does not explicitly teach wherein the control system is configured to control the transducer array to cause different subsets of the transducer elements to sequentially fire for capturing sub-aperture full matrix capture (FMC) data.
Whereas, Younghouse, in an analogous field of endeavor, teaches wherein the control system is configured to control the transducer array to cause different subsets of the transducer elements to sequentially fire for capturing sub-aperture full matrix capture (FMC) data (Fig. 1; see para. 0019 "Embodiments of the present invention provide a method for efficiently achieving full-matrix ultrasonic data capture...as the probe moves from one collection location to the next, a data matrix at a prior collection location is gradually filled in as the probe moves to subsequent collection locations.'").
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 sequentially firing transducer elements, as disclosed in Padwal in view of Abraham, by capturing sub-aperture full matrix capture (FMC) data, as disclosed in Younghouse. One of ordinary skill in the art would have been motivated to make this modification in order to improve data collection efficiency and overcome redundancies and strain on storage capacity, as taught in Younghouse (see para. 0016).
Furthermore, regarding claim 7, Padwal further teaches wherein FMC data from multiple subsets of transducer elements is utilized to generate the uterus image of the entire uterus (see para. 0101 "For example, processing described herein may be used to perform.. uterus imaging...").
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Hamelmann et al. (US 20230255594 A1, published August 17, 2023) discloses the various transducer elements TE are pre-tilted in such a way as to counteract the convergence of the fields of view FOV-1, FOV-2, FOV-3, FOV-4, FOV-5 resulting from bending the ultrasound transducer array T around the skin S of the pregnant woman's abdomen (Fig. 2).
Kossoff (US 4070905 A, published January 31, 1978) discloses sequentially activating different groups of adjacent transducer elements within said array to direct a pulse of ultrasonic energy along a beam into the object and receive echoes reflected along the beam in each of a plurality of angular directions in a single plane.
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.
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 on 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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.C./Examiner, Art Unit 3798
Prosecution Insights