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 § 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 1-11 and 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.
In claim 1, lines 3-5 are vague. In line 3, “configures algorithms implemented by the plurality of electrodes” is vague as it is unclear how electrodes use/implement algorithms. Electrodes are conductive pieces of material that are used to pick up the patient’s electrical signals and it is unclear how these electrodes use the algorithms. In addition, it is unclear if there are multiple algorithms used by the electrodes, or if the system configures multiple algorithms over its use, that then transmits an algorithm one at a time for the electrodes to use over time. In line 4, “control acquisition of sensed biopotential signals from the wearable device” is vague as line 2 has not set forth any element(s) in the wearable device that acquires signals or controls acquisition (or that holds algorithms). In addition, the paragraph is vague as the fetal monitoring system does not do anything with the algorithms such as transmit them to the wearable device, and the wearable device has not been set forth to use algorithms or receive them from the fetal monitoring system. In line 7, “maternal or fetal biopotential signals detected…” is vague as line 4 also mentions “sensed biopotential signals”. It is unclear if these two are the same or different elements, and if the algorithms are meant to control these biopotential signals also. If they are the same signals then it is suggested to use in line 4, “to control acquisition of at least one of maternal or fetal biopotential signals detected from the wearable device” and in line 7, “the at least one of maternal…”.
Claim 20 uses the same or similar language and is also vague and indefinite.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The subject matter which was not described in the original disclosure is a fetal monitoring system “configuring algorithms implemented by the plurality of electrodes” to control acquisitions of sensed biopotential signals from the wearable device, in combination with the other elements or functions in the claim(s).
As discussed above in the 112b rejections, it is unclear as to exactly what this claimed paragraph/phrase means. As seen in the disclosure, such as paragraph 30 of the specification, the fetal monitoring system configures algorithms implemented by wearable device 150, patient computing device 200 and/or FMS 300 to control acquisition of the sensed biopotential signals from wearable device. The disclosure does not disclose the algorithms “implemented by the plurality of electrodes” and it is unclear as to what exactly this means.
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.
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 1-2, 5, 8-11, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wolfberg (2013/0102856) in view of Shennib (2005/0277841). The new limitations to claims 1 and 20 are vague, unclear, and make the claims difficult to interpret. As best understood by the examiner, Wolfberg in view of Shennib meets the claims as follows.
Wolfberg discloses the use of a wearable torso band with dry electrodes (e.g. figure 5, paras. 13, 56, 63, etc.) where leads (i.e. pairs of electrodes, positive and reference/negative, para. 35, etc.) are used to sense the maternal and/or fetal signals, where the pairs can have one common reference electrode and the pairs are constantly/dynamically changed during the monitoring session by a computing device to select new electrodes for the pairs based on processing the maternal/fetal signals using different factors, such as fetal position changes, loss of contact, changes in lead signals, etc. (e.g. paras. 58, 59, etc.). Wolfberg does not disclose a separate fetal system to configure an algorithm(s) used to control acquiring the sensed signals from the wearable device. Shennib discloses a fetal monitoring/programming system (e.g. paras. 60-62, 24, figure 14, etc.) that wirelessly configures the wearable device and corresponding computer system to control acquisition of sensed biopotential signals from the wearable device (e.g. para. 60, algorithm(s) for sampling rate, filtering algorithm, electrode position and selection, etc.) so that the wearable device and computer system can be updated with new algorithms that will allow the system to better sense the patient’s condition. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Wolfberg, with an additional fetal monitoring/programmer system to configure an algorithm(s) used to control acquiring the sensed signals from the wearable device, as taught by Shennib, since it would provide the predictable results of allowing the wearable device and corresponding computer system to be updated with new algorithms that will allow the device and computer system to better sense the patient’s condition from the electrodes.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wolfberg in view of Shennib (i.e. “modified Wolfberg”) and further in view of Mohamad et al (WO 2018/218310). Modified Wolfberg discloses the claimed invention except for the programmer/fetal monitoring system receiving data regarding the patient from one or more data sources, such as electronic health records, where the retrieved data is used to further configure the algorithms. Mohamad teaches that it is known for a programmer to receive data regarding the patient from one or more data sources, such as electronic health records, to better configure algorithms with machine learning/AI so that prior history of the patient can be taken into account when programming/updating the monitoring system’s sensing (e.g. figure 5, abstract, paras. 164, 166, 194, 208, 217, etc.). It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by modified Wolfberg, with a programmer to receive data regarding the patient from one or more data sources to better configure algorithms with machine learning/AI, as taught by Mohamad, since it would provide the predictable results of using the prior history of the patient when programming/updating the monitoring systems so that the monitoring system can better sense the patient’s condition.
Claims 3-4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Wolfberg in view of Shennib (i.e. “modified Wolfberg”). Modified Wolfberg discloses the claimed invention except for also selecting one of the electrodes as a drive electrode to supply a biasing voltage to a driven electrode to bias the body of the patient to the same potential to reduce an impact of bias offset at each of the measuring locations of the electrodes, or including a temperature sensor or accelerometer in the wearable device. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Wolfberg, with selecting one of the electrodes as a drive electrode to supply a biasing voltage to a driven electrode to bias the body of the patient to the same potential to reduce an impact of bias offset at each of the measuring locations of the electrodes, or including a temperature sensor or accelerometer in the wearable device, as is well known and common knowledge in the art (mpep 2144I, 2144.03) since it would provide the predictable results of increasing ECG measurement performance by reducing common mode noise or signals that have the same phase, and allowing other vital signs such as temperature to be monitored to better determine the patient’s condition.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection necessitated by amendment.
Conclusion
The prior art made of record is considered pertinent to applicant's disclosure and shows the well-known and common knowledge in the art features.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/Primary Examiner, Art Unit 3792 12/25/25
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