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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-4, 11-13 and 18 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US 20140012190 A1 to Ben-David et al. (hereinafter “Ben-David”).
Regarding Claims 1 and 11, Ben-David teaches a system for monitoring and stimulating uterine muscles, the system comprising:
a plurality of surface electrodes (12; see e.g. Para. 24: “Uterine electrical activity sensors 12 may include electromyogram (EMG) electrodes”) configured to be disposed on an abdomen of a maternal patient (see Para. 24 and FIG. 2B);
a control system configured to:
obtain electromyography (EMG) data via the plurality of surface electrodes (see e.g. Para. 24);
detect at least one indicator of insufficient uterine activity based on the EMG data (see e.g. Para. 12: “in one non-limiting embodiment of the invention, measuring uterine contraction is done with an electrical uterine monitor (EUM), examples of which are described below with reference to FIGS. 2A-2B and 3. The sensed measurements are used to regulate uterine muscular activity by continuously comparing the sensed measurements to a desired level. If the measured contraction amplitude is stronger than the desired level, a contraction reduction drug or pulse is applied. If the measured contraction amplitude is too weak, a contraction enhancer is applied”); and
generate stimulation pulses between at least two of the plurality of surface electrodes in response to detecting the at least one indicator of insufficient uterine activity (see e.g. Paras. 12-13, 15, and 30).
Regarding Claims 3 and 18, Ben-David further teaches wherein the stimulation pulses are generated between an upper electrode positioned on an upper portion of the maternal abdomen and a lower electrode positioned on a lower portion of the maternal abdomen (see e.g. FIG. 2B and Para. 30).
Regarding Claims 4 and 12-13, Ben-David further teaches wherein the at least one indicator of insufficient uterine activity is based on at least one of a frequency of the EMG data during at least one uterine contraction, an amplitude of the EMG data during the at least one uterine contraction, a duration of the at least one uterine contraction, and a contraction frequency of the at least one uterine contraction, wherein the at least one indicator of insufficient uterine activity includes at least one of an EMG frequency of less than a threshold frequency and an EMG amplitude of less than a threshold amplitude (see e.g. Para. 12: “If the measured contraction amplitude is stronger than the desired level, a contraction reduction drug or pulse is applied. If the measured contraction amplitude is too weak, a contraction enhancer is applied”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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 2, 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-David in view of US 2014/0058473 A1 to Garfield et al. (hereinafter “Garfield”).
Regarding Claims 2, 14 and 16, Ben-David fails to discuss which stimulation parameter(s) are specifically controlled. However, frequency, amplitude and pulse duration are incredibly well-known electrical stimulation parameters which are known to be controlled to produce different outcomes. Another reference, Garfield, teaches automatically adjusting all of these parameters based on uterine contraction information (see e.g. Para. 38: “In another embodiment, the control module 24 can automatically regulate and modify the electrical current output produced by the current source 26 based on input from electrical contractile activity of the patient's uterus, which can be transmitted to the control module 24 via pick-up wires, a signal conditioner, and/or after-conditioning wires (not shown). The control module 24 can regulate and modify the produced electrical current by changing the electrical stimulation pulse-width, current amplitude, pulse train duration, and/or the pulse frequency according to a pre-programmed algorithm”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Ben-David to have the control system determine the stimulation frequency, amplitude and pulse duration based on the sensed EMG data because it would advantageously allow the system to tailor the treatment to different levels of contraction being sensed.
Regarding Claim 15, Ben-David teaches further comprising obtaining further EMG data via the plurality of surface electrodes during generation of the stimulation pulses; detecting a stimulation response based on the EMG data; determining a stimulation adjustment based on the stimulation response; generating a second set of stimulation pulses between the at least two of the plurality of surface electrodes based on the stimulation adjustment (see e.g. “closed loop control system” in Para. 4 and “The EUM and processor may operate in a control loop with an electrical signal generator or drug delivery system for automatic application of the electrical signal or drug” in Para. 6).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-David in view of US 2003/0125635 A1 to Maalouf et al. (hereinafter “Maalouf”).
Regarding Claim 5, Ben-David teaches measuring EMG amplitude compared to a threshold as noted above, but fails to specifically teach comparing both amplitude and frequency of the EMG to thresholds. Another reference, Maalouf, teaches that both amplitude and frequency of EMG correspond to amplitude and frequency of uterine contractions (see e.g. Para. 3). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Ben-David to also consider the frequency of the EMG data because it would enhance the overall diagnostic accuracy of the device.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-David in view of Garfield as applied to claim 15 above, and further in view of US 2018/0296834 A1 to John et al. (hereinafter “John”).
Regarding Claim 17, Ben-David as modified above fails to specifically teach ceasing stimulation and generating an alert if the response is insufficient. However, this is a well known practice in the stimulation arts as a general matter, since it is widely understood to be undesirable to deliver stimulation if sensed parameter(s) are not suitable. As one example, John teaches this concept in another stimulation device (see e.g. Para. 72: “Impedance data obtained by the sensing/impedance module 50 can be evaluated by the monitoring module 46 and cause the stimulation to stop, or a patient to be issued a notification, if the impedance drops below a minimum defined threshold.”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Ben-David to cease stimulation and generate an alert of insufficient response because it would allow a user to make adjustments to ensure a proper therapy is delivered.
Claims 6-10 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-David in view of US 2023/0114033 A1 to Shazly et al. (hereinafter “Shazly”).
Regarding Claims 6-10 and 19-20, Ben-David teaches evaluating EMG as an indicator of insufficient uterine activity including sensing at least a EMG amplitude compared to some threshold as discussed above, but fails to specifically teach that this evaluation is based on a current labor phase of the maternal patient, and more specifically based on the antepartum, intrapartum, and postpartum phases, each with their respective thresholds and each having a respective trained machine learning model trained based on data specific to that phase. Another reference, Shazly, teaches the use of distinct machine learning models specific to different phases of labor for diagnostic analysis specific to each phase (see e.g. Paras. 68-70) and acknowledges the known phases of labor include antepartum, intrapartum and postpartum (see Para. 73). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Ben-David to further categorize the data analysis into the multiple phases of labor, each having its own data and machine learning model, because it would predictably and advantageously increase the accuracy of the diagnostic determinations by accounting for variations in natural uterine contraction characteristics which change based on the phase of labor.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-David in view of Shazly as applied to claim 20 above, and further in view of Maalouf.
Regarding Claim 21, Ben-David as modified above teaches measuring EMG amplitude compared to a threshold as noted above, but fails to specifically teach comparing both amplitude and frequency of the EMG to thresholds. Another reference, Maalouf, teaches that both amplitude and frequency of EMG correspond to amplitude and frequency of uterine contractions (see e.g. Para. 3). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Ben-David to also consider the frequency of the EMG data because it would enhance the overall diagnostic accuracy of the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NIKETA PATEL can be reached at (571)-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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