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Claims 1-20 remain pending, with claims 12-20 withdrawn, in the application in response to the applicant’s amendments to the rejections previously set forth in the Non-Final Office Action mailed 05/26/2026.
Response to Arguments
Applicant’s arguments, see pg. 1-2, filed 07/29/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 (Padwal in view of Abraham) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ross in view of Hamelmann.
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, 8, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ross (US 7399278 B1, published July 15, 2008) in view of Hamelmann et al. (US 20230255594 A1, published August 17, 2023), hereinafter referred to as Ross and Hamelmann, respectively.
Regarding claim 1, Ross teaches an ultrasound system (Fig. 1, ultrasound system 100), comprising:
an transducer array configured to acquire scan data, 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 col. 2, lines 16-19, 42-44 – “For example, system 100 may be implemented with an array of transducer elements which moves an ultrasound beam vertically and/or horizontally across a three-dimensional region by a manual or mechanical operation... Ultrasound data 120 generated by transducer 110 may be in the form of a series of data representing multiple scan planes of the scanned uterus.” Array sized to image entire uterus);
a control system comprising at least one hardware controller (see col. 1, lines 66-67 – “In other instances, well-known circuits, components, software programs, structures and techniques have not been shown in detail...” where a controller is inherent and known in the art) and configured to:
operate the transducer array to acquire the scan data of the entire uterus of the maternal patient at predetermined intervals (Fig. 1; see col. 2, lines 42-44 – “Ultrasound data 120 generated by transducer 110 may be in the form of a series of data [predetermined intervals] representing multiple scan planes of the scanned uterus.”); and
generate a uterus image of the entire uterus at the predetermined intervals based on the scan data (Fig. 2; see – “In functional block 210, an ultrasound apparatus is used to generate a series of data representing two-dimensional slices (“scan planes”) of the uterus being scanned.”; see col. 6, lines 11-15 – “And, data representing different regions of the uterus are combined to construct a three-dimensional representation of the entire uterus. Any suitable method may be utilized to combined data representing different scanned regions.”).
Ross teaches a transducer array on an abdomen of a maternal patient imaging an entire uterus (see col. 2, lines 40-42 – “Ultrasound data 120 of a uterus acquired by scanning an abdomen of a pregnant women are collected in a memory for subsequent processing.”), but does not explicitly teach where the transducer array is disposed on a flexible array.
Whereas, Hamelmann, in an analogous field of endeavor, teaches a flexible substrate configured to be maintained on an abdomen of a maternal patient; and a transducer array disposed on the flexible substrate (Fig. 2; see para. 0017 – “In embodiments of the present invention, multiple ultrasound transducer elements TE, such as piezoelectric transducer elements (PZTs), are thus embedded in a flexible ultrasound transducer array T.”; see para. 0029 – “The transducer array 110 may be made out of any suitable material, for example, by integrating the transducer elements 130 into a fabric or a belt, which could be wrapped around the subject's body.”).
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 Ross, by having the transducer array disposed in a flexible substrate, as taught in Hamelmann. One of ordinary skill in the art would have been motivated to make this modification in order to monitor the fetal heart rate continuously for various fetal heart locations, and the possibility of monitoring twins or triplets, as taught in Hamelmann (see para. 0014).
Furthermore, regarding claim 8, Hamelmann 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 (Fig. 4; see para. 0029 – “The transducer array 110 may be made out of any suitable material, for example, by integrating the transducer elements 130 into a fabric or a belt, which could be wrapped around the subject's body.”).
Furthermore, regarding claim 10, Hamelmann 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. 2, transducer array T width is greater than transducer array height).
Furthermore, regarding claim 11, Hamelmann 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. 2, width and height of transducer array T (transducer area) to measure entire fetus, which is in uterus; see para. 0025 – “In another embodiment of the invention, the ultrasound transducer array T with pre-tilted transducer elements TE allows to generate a FOV large enough to insonify the whole fetus, allowing to monitor fetal movements, such as fetal limb movement.”).
The motivation for claims 8 and 10-11 was shown previously in claim 1.
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ross in view of Hamelmann, 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, Ross in view of Hamelmann teaches all of the elements disclosed in claim 1 above.
Ross in view of Hamelmann teaches generating uterus images, but does not explicitly teach identifying postpartum hemorrhage (PPH) 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.Transversegrayscale 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 Ross in view of Hamelmann, by also identifying postpartum hemorrhage based on uterus images, as disclosed inVardar. 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. 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 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 Ross in view of Hamelmann, as applied to claim 1 above, and in further view of Younghouse et al. (US 20200200715A1, published June 25, 2020), hereinafter referred to as Younghouse.
Regarding claim 6, Ross in view of Hamelmann teaches all of the elements disclosed in claim 1 above.
Ross in view of Hamelmann teaches sequentially firing transducer elements (Ross: see col. 2, lines 42-44 – “Ultrasound data 120 generated by transducer 110 may be in the form of a series of data representing multiple scan planes of the scanned uterus.”), 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 Ross in view of Hamelmann, 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, Ross further teaches wherein FMC data from multiple subsets of transducer elements is utilized to generate the uterus image of the entire uterus (Fig. 2; see – “In functional block 210, an ultrasound apparatus is used to generate a series of data representing two-dimensional slices (“scan planes”) of the uterus being scanned.”; see col. 6, lines 11-15 – “And, data representing different regions of the uterus are combined to construct a three-dimensional representation of the entire uterus. Any suitable method may be utilized to combined data representing different scanned regions.”).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ross in view of Hamelmann, as applied to claim 1 above, and in further view of Padwal, hereinafter referred to as Padwal.
Regarding claim 9, Ross in view of Hamelmann teaches all of the elements disclosed in claim 1 above.
Ross in view of Hamelmann teaches a flexible substrate, but does not explicitly teach where the flexible substrate is a patch configured to adhere to the abdomen.
Whereas, Padwal, in an analogous field of endeavor, 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 [patch] onto the patient's abdomen...").
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 a flexible substrate, as disclosed in Ross in view of Hamelmann, by having the flexible substrate as a patch configured to adhere to the abdomen, as disclosed in Padwal. One of ordinary skill in the art would have been motivated to make this modification in order to ensure that housing contacts the patient's abdomen along the entire length of housing, as taught in Padwal (see para. 0029).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Errico et al. (US 20240065668 A1, published February 29, 2024) discloses generating a quantitative assessment of ovarian and pelvic organ mobility based on ultrasound imaging.
Rouet et al. (US 20200090327 A1, published March 19, 2020) discloses receive a sequence of 2-D ultrasound image frames of a prenatal entity from an ultrasound probe.
Moradi et al. (US 20190041505 A1, published February 7, 2019) discloses detection, diagnosis, and/or assessment of cancers in any anatomic site, including the uterus, based on ultrasound data.
Douglas (US 20210007710 A1, published January 14, 2021) discloses the aiming mode may be used to position the ultrasound robe to measure the volume of an area of interest (e.g., uterus volume measurement).
Choi et al. (US 20190099160 A1, published April 4, 2019) discloses ultrasound imaging organs such as the uterus.
Soldner (US 4058114 A, published November 15, 1977) discloses an ultrasonic applicator with an ultrasound scanning system for the surface-wide ultrasonic scanning of the body region which is to be punctured, such as the uterus, and a display or viewing apparatus for rendering visible the echo-section images.
Varghese et al. (US 20040210136 A1, published October 21, 2004) discloses applies elastography to measurements of the uterus and cervix using an ultrasonic imaging system.
Goldberg (US 3780725 A, published December 25, 1973) discloses fetal heartbeat monitoring system in which a plurality of ultrasonic beams are transmitted at different angles into the uterus of an expectant mother. A plurality of receiving transducers are inclined at different angles for receiving the signal as it is reflected from the fetus and/or uterus walls.
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