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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 30 Jan 2024, 04 Aug 2025, 29 Aug 2025, and 10 Dec 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
Specification
The abstract of the disclosure is objected to because “a FMS” should read “an FMS”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informality:
“comprises a comprises” should read “comprises” ([0009]).
Appropriate correction is required.
Claim Objections
Claims 1-2, 14-15, and 20 are objected to because of the following informalities:
“at least one of,” should read “at least one of” (claims 1, 14, and 20); and
“the group” should read “a group” (claims 2 and 15).
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation uses a generic placeholder (i.e., “component) that is coupled with functional language, which is configured to be computer implemented. See MPEP 2181.II.B. Computer-Implemented Means-Plus-Function Limitations.
Because these computer-implemented limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, the specification must disclose an algorithm for performing the claimed function. See, e.g., Noah Systems Inc. v. Intuit Inc., 675 F.3d 1302, 1312, 102 USPQ2d 1410, 1417 (Fed. Cir. 2012); Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239.
If applicant does not intend to have these computer-implemented limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (see the proposed Examiner’s amendment) so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim 1 recites the limitation “a context component that determines context information regarding an operating context of the fetal monitoring system, the context information comprising a number of the fetal sensor devices activated for monitoring a corresponding number of fetuses of a single mother in association with positioning of the fetal sensor devices on an external body of the single mother”. Since this claim limitation invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, “context component” in claim 1 and its dependent claims have been interpreted to be performed by the algorithm described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the algorithm for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph computer-implemented limitation:
[0073] … The mechanism via which the master context component 502 determines the number of active FSDs 104 can vary. For example, in some implementations, the master context component 502 can detect when an FSD 104 has been activated for a monitoring session (e.g., turning on and/or entering an active fetal sensing mode) based on reception of an activation signal from the FSD 104 and/or when an FSD 104 is placed on or near the abdomen of the mother 108 based on reception of a corresponding application signal from the FSD 104 (e.g., as determined by the FSD 104 using one or more contact sensors, using one or more proximity sensors, or the like). For instance, in some scenarios in which the mother has two or more fetuses, the clinical workflow typically involves individually activating each FSD 104 at time, placing the FSD on the mother's abdomen in association with applying gel, moving the FSD about the mother's abdomen until the FSD 104 picks up a fetal heart of one of the fetuses and then setting the FSD 104 at that position. Thereafter, another FSD is activated and applied to the mother in the same manner in association with detecting another fetal heart, and so on. In accordance with this usage scenario, the master context component 502 can determine each time an FSD 104 is activated and applied to the same mother based on reception of information from the corresponding FSD 104 indicating its active status.
For purposes of the examination, Examiner will interpret the claimed function of “context component” to be performed by the algorithm disclosed in [0073] of the specification of the instant application, or equivalents thereof.
Claim 1 recites the limitation “a configuration component that configures respective operating modes of the fetal sensor devices based on the context information and in accordance with a configuration protocol that varies the respective operating modes under different operating contexts of the fetal monitoring system”. Since this claim limitation invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, “context component” in claim 1 and its dependent claims have been interpreted to be performed by the algorithm described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the algorithm for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph computer-implemented limitation:
[0076] In some embodiments, the master configuration component 506 can configure the operating parameters of the respective active FSDs 104 based on the operating context (e.g., based on the context information) of the FMS 100. With these embodiments, the master configuration component 506 can determine the optimal operating parameters (e.g., operating mode, either FDM mode or TDM mode, carrier frequency, and PRR) for the respective FSDs based on the current operating context (e.g., the number of active FSDs 104 and corresponding number of fetuses, the depths of the fetuses, and other contextual parameters discussed herein) and using the master configuration protocol 506 and/or one or more configuration optimization functions 512. The master configuration component 506 can further send configuration information to the respective FSD 104 identifying the particular operating parameters to be applied by each FSD 104 and instructing them to configure themselves accordingly. To this end, based on reception of the configuration information from the monitor device 500, the respective FSDs 104 can be configured to operate in accordance with their assigned operating parameters. In some embodiments, the master configuration component 506 can further reconfigure the operating parameters of one or more of the FSDs 104 (e.g., in accordance with the master configuration protocol 506 and/or the using the one or more configuration optimization functions 512) over the course of the monitoring session using updated configuration commands based on changes to the operating context.
For purposes of the examination, Examiner will interpret the claimed function of “configuration component” to be performed by the algorithm disclosed in [0076] of the specification of the instant application, or equivalents thereof.
Claims 14 and 20 each recites the limitation “determining … context information regarding an operating context of the fetal monitoring system, the context information comprising a number of fetal sensor devices activated for monitoring a corresponding number of fetuses of a single mother in association with positioning of the fetal sensor devices on an external body of the single mother”. Since this claim limitation invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, the claimed computer-implemented limitation has been interpreted to be performed by the algorithm described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the algorithm for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph computer-implemented limitation:
[0073] … The mechanism via which the master context component 502 determines the number of active FSDs 104 can vary. For example, in some implementations, the master context component 502 can detect when an FSD 104 has been activated for a monitoring session (e.g., turning on and/or entering an active fetal sensing mode) based on reception of an activation signal from the FSD 104 and/or when an FSD 104 is placed on or near the abdomen of the mother 108 based on reception of a corresponding application signal from the FSD 104 (e.g., as determined by the FSD 104 using one or more contact sensors, using one or more proximity sensors, or the like). For instance, in some scenarios in which the mother has two or more fetuses, the clinical workflow typically involves individually activating each FSD 104 at time, placing the FSD on the mother's abdomen in association with applying gel, moving the FSD about the mother's abdomen until the FSD 104 picks up a fetal heart of one of the fetuses and then setting the FSD 104 at that position. Thereafter, another FSD is activated and applied to the mother in the same manner in association with detecting another fetal heart, and so on. In accordance with this usage scenario, the master context component 502 can determine each time an FSD 104 is activated and applied to the same mother based on reception of information from the corresponding FSD 104 indicating its active status.
For purposes of the examination, Examiner will interpret the claimed limitation “determining … context information regarding an operating context of the fetal monitoring system ….” to be performed by the algorithm disclosed in [0073] of the specification of the instant application, or equivalents thereof.
Claims 14 and 20 each recites the limitation “configuring … respective operating modes of the fetal sensor devices based on the context information and in accordance with a configuration protocol that varies the respective operating modes under different operating contexts of the fetal monitoring system”. Since this claim limitation invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, “context component” in claim 1 and its dependent claims have been interpreted to be performed by the algorithm described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the algorithm for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph computer-implemented limitation:
[0076] In some embodiments, the master configuration component 506 can configure the operating parameters of the respective active FSDs 104 based on the operating context (e.g., based on the context information) of the FMS 100. With these embodiments, the master configuration component 506 can determine the optimal operating parameters (e.g., operating mode, either FDM mode or TDM mode, carrier frequency, and PRR) for the respective FSDs based on the current operating context (e.g., the number of active FSDs 104 and corresponding number of fetuses, the depths of the fetuses, and other contextual parameters discussed herein) and using the master configuration protocol 506 and/or one or more configuration optimization functions 512. The master configuration component 506 can further send configuration information to the respective FSD 104 identifying the particular operating parameters to be applied by each FSD 104 and instructing them to configure themselves accordingly. To this end, based on reception of the configuration information from the monitor device 500, the respective FSDs 104 can be configured to operate in accordance with their assigned operating parameters. In some embodiments, the master configuration component 506 can further reconfigure the operating parameters of one or more of the FSDs 104 (e.g., in accordance with the master configuration protocol 506 and/or the using the one or more configuration optimization functions 512) over the course of the monitoring session using updated configuration commands based on changes to the operating context.
For purposes of the examination, Examiner will interpret the claimed limitation “configuring … respective operating modes of the fetal sensor devices based on …” to be performed by the algorithm disclosed in [0076] of the specification of the instant application, or equivalents thereof.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “a context component that determines context information regarding an operating context of the fetal monitoring system, the context information comprising a number of the fetal sensor devices activated for monitoring a corresponding number of fetuses of a single mother in association with positioning of the fetal sensor devices on an external body of the single mother”. The metes and bounds of the claim are unclear in view of this limitation. In particular, the limitation, nor the claim as a whole, requires the number of fetuses being monitored is more than one fetus and each of these fetuses be monitored by a fetal sensor device, as the limitation and the claim as a whole suggests that a single fetus may be being monitored by more than one fetal sensor devices. However, a review of the specification of the instant application discloses more than one fetus each being monitored by a respective fetal sensor device (see at least [0073]). Claims 2-13 inherit the deficiency by the nature of their dependency on claim 1. For the purposes of the examination, the limitation as well as the claim as a whole are being given a broadest reasonable interpretation incorporating “wherein the context information further comprises respective anatomical positions of the fetuses within the womb of the single mother relative to positions of the respective ones of the fetal sensor devices as positioned on the external body of the single mother” from dependent claim 6, thus requiring the number of fetuses be more than one and each of the fetuses being monitored by a respective fetal sensor device. See the attached proposed Examiner’s amendment.
Claim 1 recites the limitation “a configuration component that configures respective operating modes of the fetal sensor devices based on the context information and in accordance with a configuration protocol that varies the respective operating modes under different operating contexts of the fetal monitoring system”. It is unclear whether the “respective operating modes of the fetal sensor devices” are the same or different from the FDM and TDM modes which each of the fetal sensor devices are configurable to operate. Claims 2-13 inherit the deficiency by the nature of their dependency on claim 1. For purposes of the examination, the limitation is being given a broadest reasonable interpretation where the “respective operating modes” are referring to the FDM and TDM modes. See the attached proposed Examiner’s amendment.
Claim 2 recites the limitation “minimizing power consumption by the respective ones of the fetal sensor devices, minimizing crosstalk between the respective ones of the fetal sensor devices, and achieving requisite depth coverage”. It is unclear whether “the respective ones of the fetal sensor devices” is referring to specific fetal sensor devices of the plurality of fetal sensor devices or not. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “minimizing power consumption by respective ones of the fetal sensor devices, minimizing crosstalk between the respective ones of the fetal sensor devices, and achieving requisite depth coverage”. See the attached proposed Examiner’s amendment.
Claim 7 recites the limitation “an operating frequency and a pulse repetition rate of the respective ones of the fetal sensor devices based on the context information”. It is unclear whether “the respective ones of the fetal sensor devices” is referring to specific fetal sensor devices of the plurality of fetal sensor devices or not. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “an operating frequency and a pulse repetition rate of respective ones of the fetal sensor devices based on the context information”. See the attached proposed Examiner’s amendment.
Claim 12 recites the limitation “configures the respective ones of the fetal sensor devices via respective configuration command signals communicated by the monitor device to the respective ones of the fetal sensor devices”. It is unclear whether “the respective ones of the fetal sensor devices” is referring to specific fetal sensor devices of the plurality of fetal sensor devices or not. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “configures respective ones of the fetal sensor devices via respective configuration command signals communicated by the monitor device to the respective ones of the fetal sensor devices”. See the attached proposed Examiner’s amendment.
Claim 13 recites the limitation “wherein each of the fetal sensor devices comprises a memory that stores the configuration component and the context component and a processor that executes the configuration component and the context component”. It is unclear whether “a memory” and “a processor” recited in the limitation is the same or different from “at least one memory” and “at least one processor” recited in claim 1, to which claim 13 depends. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein each of the fetal sensor devices comprises the at least one memory that stores the configuration component and the context component and the at least one processor that executes the configuration component and the context component”. See the attached proposed Examiner’s amendment.
Claims 14 and 20 each recites the limitation “determining … context information regarding an operating context of the fetal monitoring system, the context information comprising a number of fetal sensor devices activated for monitoring a corresponding number of fetuses of a single mother in association with positioning of the fetal sensor devices on an external body of the single mother”. The metes and bounds of each of the claims are unclear in view of this limitation. In particular, the limitation, nor each claim as a whole, requires the number of fetuses being monitored is more than one fetus and each of these fetuses be monitored by a fetal sensor device, as the limitation and each claim as a whole suggests that a single fetus may be being monitored by more than one fetal sensor devices. However, a review of the specification of the instant application discloses more than one fetus each being monitored by a respective fetal sensor device (see at least [0073]). Claims 15-19 inherit the deficiency by the nature of their dependency on claim 14. For the purposes of the examination, the limitation as well as each of claims 14 and 20 as a whole are being given a broadest reasonable interpretation incorporating “wherein the context information further comprises respective anatomical positions of the fetuses within the womb of the single mother relative to positions of the respective ones of the fetal sensor devices as positioned on the external body of the single mother” from dependent claim 18, thus requiring the number of fetuses be more than one and each of the fetuses being monitored by a respective fetal sensor device. See the attached proposed Examiner’s amendment.
Claim 15 recites the limitation “minimizing power consumption by the respective ones of the fetal sensor devices, minimizing crosstalk between the respective ones of the fetal sensor devices, and achieving requisite depth coverage”. It is unclear whether “the respective ones of the fetal sensor devices” is referring to specific fetal sensor devices of the plurality of fetal sensor devices or not. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “minimizing power consumption by respective ones of the fetal sensor devices, minimizing crosstalk between the respective ones of the fetal sensor devices, and achieving requisite depth coverage”. See the attached proposed Examiner’s amendment.
Allowable Subject Matter
Claims 1-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action, as well as incorporating the limitation in claims 2 and 15 into the independent claims 1, 14, and 20, respectively.
The following is a statement of reasons for the indication of allowable subject matter:
When the claims are considered as whole as presented in the attached proposed Examiner’s amendment, prior arts do not disclose at least determining context information regarding an operating context of the fetal monitoring system, the context information comprising a number of fetal sensor devices activated for monitoring a corresponding number of fetuses of a single mother in association with positioning of the fetal sensor devices on an external body of the single mother, wherein the context information further comprises respective anatomical positions of the fetuses within a womb of the single mother relative to positions of respective fetal sensor devices of the fetal sensor devices as positioned on the external body of the single mother, wherein each the fetal sensor devices respectively comprise ultrasound transducers configured to measure signals representative of one or more fetal parameters of a single fetus using doppler-based ultrasound technology, the one or more fetal parameters comprising at least one of fetal heart rate (FHR), fetal movement, or fetal depth, and wherein each of the fetal sensor devices are configurable to operate using either a frequency domain multiplexing (FDM) mode or a time domain multiplexing (TDM) mode; and configuring the operating modes of the fetal sensor devices based on the context information and in accordance with a configuration protocol that varies the operating modes under different operating contexts of the fetal monitoring system, wherein the configuration protocol further achieves one or more defined optimization criteria under the different operating contexts, the one or more defined optimization criteria selected from the group consisting of: minimizing power consumption by the respective ones of the fetal sensor devices, minimizing crosstalk between the respective ones of the fetal sensor devices, and achieving requisite depth coverage. In particular, Franck et al. (US PG Pub No. 2022/0192525) discloses at least determining a number of ultrasound fetal sensor devices activated for monitoring a plurality of fetuses of a single mother in association with positioning of the fetal sensor devices and configuring operating modes based on the number of activated fetal sensor devices and the anatomical positions of the fetuses (Fig. 5-6 and [0180]-[0187]). Additionally, Wohlschlager et al. (US PG Pub No. 2018/0317878) discloses determining a number of ultrasound fetal devices activated for monitoring a plurality of fetuses of a single mother and configuring operating modes based on the number of activated fetal sensor devices and the anatomical positions of the fetuses ([0020]-[0024]). However, neither Franck et al. nor Wholschlager et al. discloses at least configuring operating modes as FDM or TDM mode for each of the activated fetal sensor devices based on the number of activated fetal sensor devices to achieve at least one of minimizing power consumption by respective ones of the fetal sensor devices, minimizing crosstalk between the respective ones of the fetal sensor devices, and achieving requisite depth coverage.
The technical advantage of the claimed invention is to improve monitoring a plurality of fetuses by overcoming the challenge of “both wired and wireless FSDs are susceptible to interference and crosstalk in scenarios in which two or more FSDs are used to respectively monitor two or more fetuses of the mother at the same time (e.g., as applied to monitoring twins, triplets, quadruplets, and so on)” and “Accordingly, (to provide) techniques for minimizing power consumption and crosstalk, while optimizing system performance” ([0005] of the specification of the instant application).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Smith et al. (US PG Pub No. 2011/0160591) discloses selectively activating ultrasound transducers to optimize detecting of a fetal heart rate (at least Abstract and Fig. 8a-c);
Charthad et al. (US PG Pub No. 2022/0265157) discloses a plurality of wireless ultrasound sensors each comprising a multiplexer for operating modes (Fig. 1, 3 and [0082]-[0086]);
Xu et al. (US PG Pub No. 2020/0261059) discloses a plurality of ultrasound sensors each comprising a multiplexer for operating modes (Fig. 1, 4 and [0031]); and
Randall et al. (US PG Pub No. 2008/0114249) discloses configuring ultrasound sensor to operate using FDM or TDM ([0048]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM 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, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Y.C./Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
3/11/26