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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-8 in the reply filed on 05/04/2026 is acknowledged. Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1 and 4-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 8-9 of U.S. Patent No. 11,534,135 in view of Lewis and Hamelmann. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are an obvious variant of the claim set from the patent only including minor differences in structure.
Claim 1 of the instant invention and claim 1 of US patent ‘135 similarly recites an ultrasound system configured to:
collect multiple sets of ultrasound data from multiple regions within a subject;
detect fetal heartbeat signals and uterine contraction signals from the multiple sets of ultrasound data;
subsequent to detection of the fetal heartbeat signals, monitor a fetal heartbeat signal among the fetal heartbeat signals by automatically steering an ultrasound beam to a 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; and
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.
Claim 1 of the instant invention further specifies an ultrasound device having a 2D array of ultrasound transducers, as disclosed in Lewis (see 103 rejection below), and a smartphone or tablet in operative communication with the ultrasound device, as disclosed in Hamelmann (see 103 rejection below).
Claim 4 of the instant invention and claim 4 of US patent ‘135 similarly recites wherein the ultrasound system is configured to monitor the fetal heartbeat signal and the uterine contraction signal alternately.
Claim 5 of the instant invention and claim 5 of US patent ‘135 similarly recites wherein each of the multiple sets of ultrasound data comprises a time series of an A-line.
Claim 6 of the instant invention and claim 6 of US patent ‘135 similarly recites 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.
Claim 7 of the instant invention and claim 8 of US patent ‘135 similarly recites 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.
Claim 8 of the instant invention and claim 9 of US patent ‘135 similarly recites 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.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,245,888. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are an obvious variant of the claim set from the patent only including minor differences in structure.
Claim 1 of the instant invention and claim 1 of US patent ‘888 similarly recites an ultrasound system comprising: an ultrasound device having a two-dimensional array of ultrasound transducers; and
a smartphone or tablet in operative communication with the ultrasound device;
wherein the ultrasound system is configured to:
collect multiple sets of ultrasound data from multiple regions within the subject;
detect fetal heartbeat signals and uterine contraction signals from the multiple sets of ultrasound data;
subsequent to detection of the fetal heartbeat signals, monitor a fetal heartbeat signal among the fetal heartbeat signals by automatically steering an ultrasound beam to a 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; and
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.
Claim 2 of the instant invention and claim 2 of US patent ‘888 similarly recites 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.
Claim 3 of the instant invention and claim 3 of US patent ‘888 similarly recites 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.
Claim 4 of the instant invention and claim 4 of US patent ‘888 similarly recites wherein the ultrasound system is configured to monitor the fetal heartbeat signal and the uterine contraction signal alternately.
Claim 5 of the instant invention and claim 5 of US patent ‘888 similarly recites wherein each of the multiple sets of ultrasound data comprises a time series of an A-line.
Claim 6 of the instant invention and claim 6 of US patent ‘888 similarly recites 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.
Claim 7 of the instant invention and claim 7 of US patent ‘888 similarly recites 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.
Claim 8 of the instant invention and claim 8 of US patent ‘888 similarly recites 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.
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 09, 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 to a 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 300 will 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 20 that 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 114 of 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:
Feldman et al. (US 5265613 A, published November 30, 1993) discloses simultaneously processing fetal heart rate and maternal input signals, and the simultaneous transmission of fetal heart rate and maternal input data to a remote output device.
Kabakov et al. (US 20120179046 A1, published July 12, 2012) discloses a patient monitor extracts the raw fetal heart and uterine activity waveforms from the audio signal and processes the waveforms to obtain an indication of fetal heart rate and an indication of uterine activity.
Schulenberg et al. (US 4984576 A, published January 15, 1991) discloses the circuit allows for the automatic determination of the distance between the heart and an ultrasonic transducer located on the body of the patient, so that the evaluation of the reflected ultrasonic signals can be limited to a small body range and spurious signals from other ranges can be suppressed.
Wohlschlager et al. (US 20200315521 A1, published October 8, 2020 with a priority date of October 2, 2018) discloses a device for placement on the abdomen of a subject to measure uterine contractions of the subject and a fetal heart rate.
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.
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/N.C./Examiner, Art Unit 3798
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