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Claims 1-20 remain pending, with claims 9-20 withdrawn, in the application in response to the applicant’s amendments to the rejections previously set forth in the Non-Final Office Action mailed 05/28/2026.
Response to Arguments
Applicant's arguments filed 08/14/2026 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Lewis is used to teach detecting fetal heartbeat signals and uterine contraction signals from ultrasound data, while Brost is used to teach automatically steering an ultrasound beam to detect fetal heartbeat signals, and Zumeris is used to teach automatically steering an ultrasound beam to detect uterine contraction signals.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Lewis Jr. (US 20140350397 A1, published November 27, 2014) in view of Hamelmann et al. (US 20190133549 A1, published May 9, 2019), Brost et al. (US 20100016744 A1, published January 21, 2010), and Zumeris et al. (US 20030153832 A1, published August 14, 2003), hereinafter referred to as Lewis, Hamelmann, Brost, and Zumeris, respectively.
Regarding claim 1, Lewis teaches an ultrasound system (Fig. 1, system 1000), comprising:
an ultrasound device having a two-dimensional array of ultrasound transducers (Fig. 1, uterine probe 10 including transducers 20 arranged in an 2D array); and
a processor in operative communication with the ultrasound device (Fig. 1, processing/monitoring unit 100 in communication with ultrasound probe 10; see para 0223 "It has been mentioned that probe 10 can be interfaced to a commercially available monitoring unit.");
wherein the ultrasound system is configured to: collect multiple sets of ultrasound data from multiple regions within a subject (Fig. 6-7; see para. 0086 "Elliptical detection areas [regions] were calculated for each transducer using the measurements taken [ultrasound data]."); and
detect fetal heartbeat signals and uterine contraction signals from the multiple sets of ultrasound data (see para. 0208 "Referring to timing diagram of FIG. 36, timing diagram of FIG. 36 illustrates operation of a probe 10 having a transducer 20 that cycles between operating in an FHR signaling configuration during periods 210 and a uterine contraction (UC) signaling configuration during periods 310.").
Lewis teaches a processor in communication with the probe, but does not explicitly teach a smartphone or tablet in operative communication with the ultrasound device.
Whereas, Hamelmann, in an analogous field of endeavor, teaches a smartphone or tablet in operative communication with the ultrasound device (Fig. 3; see para. 0039 "The user device is preferably a computing device, e.g., a smart phone or a tablet."; see para. 0046 "The echo signals received by the transducer elements 318 [of ultrasound device 100] may be transmitted to the user device 320 [smartphone/tablet] via the communication channel 302, which can be wired cables or wireless connection means.").
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 processor of the ultrasound system, as disclosed in Lewis, by having the processor within a smartphone or tablet, as disclosed in Hamelmann. One of ordinary skill in the art would have been motivated to make this modification in order to improve the portability of the ultrasound system.
Lewis in view of Hamelmann teaches detecting fetal heartbeat signals, and determining signal quality (Lewis: see para. 0213 "Signal quality can be determined based on one or more signal parameter, e.g. signal strength and/or a presence of a detectable shift in the signal over time."), but does not explicitly teach steering an ultrasound beam based on a quality of the fetal heartbeat signal.
Whereas, Brost, in an analogous field of endeavor, teaches subsequent to detection of the fetal heartbeat signals, monitor a fetal heartbeat signal among the fetal heartbeat signals by automatically steering an ultrasound beam toa first region among the multiple regions within the subject to collect first further ultrasound data from the first region based on a quality of the fetal heartbeat signal (see para. 0028 "In response to the positioning commands the beam-steering system 300will drive the ultrasound transducer 302 in such a manner as to optimize the quality of the ultrasonic signal received by the transducer (i.e., to maximize the heart beat-containing information in the pulse signals received by the transducer).").
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 detecting fetal heartbeat signals, as disclosed in Lewis in view of Hamelmann, by also steering an ultrasound beam based on a quality of the fetal heartbeat signal, as disclosed in Brost. One of ordinary skill in the art would have been motivated to make this modification in order to dynamically find and/or track the moving fetal heart, as taught in Brost (see para. 0028).
Lewis in view of Hamelmann and Brost teaches detecting uterine contraction signals, and determining signal quality (Lewis: see para. 0213- "Signal quality can be determined based on one or more signal parameter, e.g. signal strength and/or a presence of a detectable shift in the signal over time."), but does not explicitly teach steering an ultrasound beam based on a quality of the uterine contraction signal.
Whereas, Zumeris, in an analogous field of endeavor, teaches subsequent to detection of the uterine contraction signals, monitor a uterine contraction signal among the uterine contraction signals by automatically steering the ultrasound beam to a second region among the multiple regions within the subject to collect second further ultrasound data from the second region based on a quality of the uterine contraction signal (Fig. 9; see para. 0047 "For example, the smart monitoring system may comprise one or more ASUs [Active Sensing Units], which may include sensor devices including: uterine contraction monitors, such as Tocodynamometer (TOCO) transducers..."; see para. 0074 "If a beam is determined to be at a non-optimal position, a PSU [Portable Sensing Unit] algorithm may provide alternative commands to one or more transmitters in an ASU to change the scanning direction or angle, and to thereby scan for more accurate signals. These commands may be provided automatically, as in the case of the scanning algorithm...").
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 detecting uterine contraction signals, as disclosed in Lewis in view of Hamelmann and Brost, by also steering an ultrasound beam based on a quality of the uterine contraction signal, as disclosed in Zumeris. One of ordinary skill in the art would have been motivated to make this modification in order to optimize the acoustic signals without changing the location of the device on the scanned body, as taught in Zumeris (see para. 0079).
Furthermore, regarding claim 2, Brost further teaches wherein the quality of the fetal heartbeat signal is based on a signal-to-noise ratio or based on an output of a statistical model (see para 0034 "In another embodiment, all crystals 505 are used to receive the ultrasonic signal reflected from the patient for possible enhancement of the signal signal-to-noise ratio.").
Furthermore, regarding claim 3, Zumeris further teaches wherein the quality of the uterine contraction signal is based on a signal-to-noise ratio or based on an output of a statistical model (see para. 0012-0013 "A signal to noise ratio may be calculated from the received vibrations for each vibration field. The process of calculating signal to noise ratios is well known. A direction whose vibration field results in a relatively high signal to noise ratio may be considered to produce a "good scan.").
Furthermore, regarding claim 4, Lewis further teaches wherein the ultrasound system is configured to monitor the fetal heartbeat signal and the uterine contraction signal alternately (see para. 0208 "Referring to timing diagram of FIG. 36, timing diagram of FIG. 36 illustrates operation of a probe 10 having a transducer 20that cycles between [alternately] operating in an FHR signaling configuration during periods 210 and a uterine contraction (UC) signaling configuration during periods 310.").
Furthermore, regarding claim 5, Lewis further teaches wherein each of the multiple sets of ultrasound data comprises a time series of an A-line (Fig. 36, time series of ultrasound data (uterine contraction and fetus heartbeat signals), where an A-line is a received signal).
The motivation for claims 2-3 was shown previously in claim 1.
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Lewis in view of Hamelmann, Brost, and Zumeris, as applied to claim 1 above, and in further view of Kim et al. (US 20150164473 A1, published June 18, 2015), hereinafter referred to as Kim.
Regarding claim 6, Lewis in view of Hamelmann, Brost, and Zumeris teaches all of the elements disclosed in claim 1 above.
Lewis in view of Hamelmann, Brost, and Zumeris teaches collecting sets of ultrasound data, but does not explicitly teach collecting a time series of ultrasound images.
Whereas, Kim, in an analogous field of endeavor, teaches wherein each of the multiple sets of ultrasound data comprises a time series of ultrasound images collected from a two-dimensional slice within the subject (see para. 0046 "FIG. 3 is a view illustrating a method in which defocused plane waves are transmitted using the 2D ultrasonic transducer array, reflected signals are received using ultrasonic transducer elements 114 of the respective rows of the 2D ultrasonic transducer array, and dynamic reception focusing is performed using the received signals.").
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 collecting sets of ultrasound data, as disclosed in Lewis in view of Hamelmann, Brost, and Zumeris, by collecting a time series of ultrasound images, as disclosed in Kim. One of ordinary skill in the art would have been motivated to make this modification in order to improve the resolution and scanning speed of the images, as taught in Kim (see para. 0008).
Furthermore, regarding claim 8, Kim further teaches wherein the ultrasound system is configured, when collecting the first further ultrasound data from the first region, to collect the first further ultrasound data without collecting ultrasound data from other of the multiple regions within the subject (see para. 0046 "FIG. 3 is a view illustrating a method in which defocused plane waves are transmitted using the 2D ultrasonic transducer array, reflected signals are received using ultrasonic transducer elements 114of the respective rows of the 2D ultrasonic transducer array, and dynamic reception focusing is performed using the received signals.").
The motivation for claim 8 was shown previously in claim 6.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lewis in view of Hamelmann, Brost, and Zumeris, as applied to claim 1 above, and in further view of Sonnenschein (US 20180014811 A1, published January 18, 2018), hereinafter referred to as Sonnenschein.
Regarding claim 7, Lewis in view of Hamelmann, Brost, and Zumeris teaches all of the elements disclosed in claim 1 above.
Lewis in view of Hamelmann, Brost, and Zumeris teaches a 2D array steering an ultrasound beam and collecting ultrasound data, but does not explicitly teach the 2D array steering the ultrasound beam in three dimensions.
Whereas, Sonnenschein, in an analogous field of endeavor, teaches wherein the ultrasound system is configured to use the two-dimensional array of ultrasonic transducers to steer the ultrasound beam in three dimensions to the first region in order to collect the first further ultrasound data (see para. 0127 "FIG. 4B shows a 2D square array that has steering capability in three dimensions with spherical or single-axis focus.").
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 2D array steering an ultrasound beam and collecting ultrasound data, as disclosed in Lewis in view of Hamelmann, Brost, and Zumeris, by having the 2D array steering the ultrasound beam in three dimensions, as disclosed in Sonnenschein. One of ordinary skill in the art would have been motivated to make this modification in order to steer the ultrasound beam more precisely.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Groberman et al. (US 20160213349 A1, published July 28, 2016) discloses a radial low frequency wide beam (˜200 khz) used for preliminary search and location of the FHB (fetal heartbeat) and a natural high frequency narrow beam (˜2 MHz) used for focused and accurate FHR (fetal heart rate) reading (Fig. 2).
Ginestet et al. (US 20150374328 A1, published December 31, 2015) discloses a cardiotocography sensing system includes a fetal heart rate (FHR) monitoring unit and a maternal uterine contraction monitoring unit to provide FHR and contraction information of a mother and fetus, where the FHR (fetal heart rate) may utilize a steerable ultrasound device to minimize the difficulties of positioning the FHR.
THIS ACTION IS MADE FINAL. 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 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
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
