DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 10/13/2024. Claims 1-9, 12, 19, 42-43 are pending and examined below.
Election/Restrictions
Claims 10-11 and 13-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/13/2024.
Applicant’s election without traverse of Species C (claim 12) in the reply filed on 10/13/2024 is acknowledged.
Claims 1-9, 12, 19, 42-43 are examined below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Regarding claim 1-9 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to receiving and manipulating data without significantly more.
Claim 11 recites “A method comprising: receiving, by a processor, a physiological characteristic of a pregnant mammal; determining, by the processor, an impact of the physiological characteristic on a behavior of an optical signal projected into the abdomen of the pregnant mammal; and determining, by the processor, a calibration factor for the optical signal responsively to the impact.”
This falls into a mental process grouping of abstract ideas. These limitations are either capable of being performed mentally by looking at measurements and making mental assessments thereafter or considered insignificant extra-solution activity.
The step of receiving a physiological characteristic of a pregnant mammal is insignificant extra-solution activity (mere data gathering).
The step of determining an impact of the physiological characteristic on a behavior of an optical signal projected into the abdomen of the pregnant mammal is a mental process that can be performed in a human mind or by a pencil and paper by a skilled clinician.
The step of determining a calibration factor for the optical signal responsively to the impact is a mental process that can be performed in a human mind.
Additionally the judicial exception is not integrated into a practical application because the additional element of processor for performing the steps is, at its broadest reasonable interpretation, a generic computer structure for performing the generic computer function of data processing, which does not qualify as an integration of the abstract idea into a practical application.
Finally, the claims analyzed as a whole do not provides any element, or combination of elements, sufficient to amount to significantly more than the mental process as only a processor is claimed. As noted previously, the addition of a generic computer structure for performing the generic computer function of data processing does not qualify as significantly more than the abstract idea itself.
Regarding dependent claims 2-9 and 12, the claims also fail to add something more to the abstract independent claims as they merely further limit the abstract idea or provide insignificant extra solution activity.
Regarding claim 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to receiving and manipulating data without significantly more.
Claim 19 recites “A method comprising: receiving, by a processor, a maternal detected electronic signal from a detector communicatively coupled to the processor, the maternal detected electronic signal corresponding to an optical signal emitted from the pregnant mammal's abdomen that has been detected by the detector and converted into the maternal detected electronic signal, the emitted optical signal being a portion of light projected, by a light source, into the pregnant mammal's abdomen; and analyzing, by the processor, the maternal detected electronic signal, to determine a physiological characteristic of the pregnant mammal; and determining, by the processor, a calibration factor for the optical signal emanating from the pregnant mammal responsively to the analysis.”
This falls into a mental process grouping of abstract ideas. These limitations are either capable of being performed mentally by looking at measurements and making mental assessments thereafter or considered insignificant extra-solution activity.
The step of receiving a maternal detected electronic signal from a detector communicatively coupled to the processor, the maternal detected electronic signal corresponding to an optical signal emitted from the pregnant mammal's abdomen that has been detected by the detector and converted into the maternal detected electronic signal, the emitted optical signal being a portion of light projected, by a light source, into the pregnant mammal's abdomen is insignificant extra-solution activity (mere data gathering).
The step of analyzing the maternal detected electronic signal, to determine a physiological characteristic of the pregnant mammal is a mental process that can be performed in a human mind or by a pencil and paper by a skilled clinician.
The step of determining a calibration factor for the optical signal emanating from the pregnant mammal responsively to the analysis is a mental process that can be performed in a human mind.
Additionally the judicial exception is not integrated into a practical application because the additional element of processor for performing the steps is, at its broadest reasonable interpretation, a generic computer structure for performing the generic computer function of data processing, which does not qualify as an integration of the abstract idea into a practical application.
Finally, the claims analyzed as a whole do not provides any element, or combination of elements, sufficient to amount to significantly more than the mental process as only a processor is claimed. As noted previously, the addition of a generic computer structure for performing the generic computer function of data processing does not qualify as significantly more than the abstract idea itself.
Regarding Claim 42, the claim is a parallel apparatus claim to that of the method claim of claim 19 and is rejected for substantially the same reasons.
Regarding dependent claim 43, the claim also fail to add something more to the abstract independent claims as they merely further limit the abstract idea or provide insignificant extra solution activity.
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.
Claim 4, and claims dependent thereof, 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.
Regarding claim 4, the claim recites the limitation “receiving, by the processor, an indication of whether the fetal signal corresponds to pre-ductal or post-ductal blood”. However, the fetal signal lacks antecedent basis and one can not ascertain the metes and bounds of the claim. As such the claim is indefinite.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 1, 7, 5, 9, 19, 42 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by US 20170188920 A1 (hereinafter referred to as “Ray”).
Regarding claim 1, Ray, a trans-abdominal fetal oximetry device, teaches a method (abstract; paragraph [0091]) comprising:
receiving, by a processor, a physiological characteristic of a pregnant mammal (receives optical signals that are associated with melanin or bilirubin concentration that can distort the reading of the fetal hemoglobin probe; paragraph [0091], [0099]);
determining, by the processor, an impact of the physiological characteristic on a behavior of an optical signal projected into the abdomen of the pregnant mammal (determined if the melanin or bilirubin reading would distort the readings of the fetal hemoglobin probe which may result in incorrectly calculating the oxygen saturation of the fetal and/or pregnant mammal’s hemoglobin; paragraph [0091], [0099]); and
determining, by the processor, a calibration factor for the optical signal responsively to the impact (distortions (caused by melanin and bilirubin) may be removed from the received signal (thus calibrating); paragraph [0091], [0099]).
Regarding claim 5, Ray teaches further comprising:
receiving, by the processor, a maternal detected electronic signal from a detector communicatively coupled to the processor, the maternal detected electronic signal corresponding to an optical signal emitted from the pregnant mammal's abdomen that has been detected by the detector and converted into the maternal detected electronic signal, the emitted optical signal being a portion of light projected, by a light source, into the pregnant mammal's abdomen (paragraph [0087], [0091], [0099]);
analyzing, by the processor, the maternal detected electronic signal, wherein the physiological characteristic of the pregnant mammal is determined responsively to the analysis (paragraph [0087], [0091], [0099]).
Regarding claim 7, Ray teaches wherein the physiological characteristic is received from at least one of an ultra-sound device, a Doppler device, an image of the pregnant mammal's abdomen, a Fitzpatrick scale reading, manually-operated calipers, a blood measurement device, an oximeter, a pulse oximeter, a scale (uses optical oximeter device; paragraph [0091]; uses ultrasonic device; paragraph [0023]).
Regarding claim 9, Ray teaches wherein the physiological characteristic is extrinsic (paragraph [0091]).
Regarding claim 19, Ray teaches a method (abstract; paragraph [0091]) comprising:
receiving, by a processor, a maternal detected electronic signal from a detector communicatively coupled to the processor, the maternal detected electronic signal corresponding to an optical signal emitted from the pregnant mammal's abdomen that has been detected by the detector and converted into the maternal detected electronic signal, the emitted optical signal being a portion of light projected, by a light source, into the pregnant mammal's abdomen (paragraphs [0087], [0091], [0099]); and
analyzing, by the processor, the maternal detected electronic signal, to determine a physiological characteristic of the pregnant mammal (determined if the melanin or bilirubin reading would distort the readings of the fetal hemoglobin probe which may result in incorrectly calculating the oxygen saturation of the fetal and/or pregnant mammal’s hemoglobin; paragraph [0091], [0099]); and
determining, by the processor, a calibration factor for the optical signal emanating from the pregnant mammal responsively to the analysis (distortions (caused by melanin and bilirubin) may be removed from the received signal (thus calibrating); paragraph [0091], [0099]).
Regarding claim 42, Ray teaches a system comprising:
a memory that stores a set of instructions for execution by a processor that is communicatively coupled to the process (has a computer (which has a memory); paragraph [0012]); and
the processor (paragraph [0012]), which when executing the set of instructions stored in the memory is configured to:
receive a physiological characteristic of a pregnant mammal (paragraph [0091]);
determine an impact of the physiological characteristic on a behavior of an optical signal projected into the abdomen of the pregnant mammal (paragraph [0091]); and
determine a calibration factor for the optical signal responsively to the impact (paragraph [0091]).
Claim(s) 1, 3, 5, 6, 8, 12, 19, 42 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by US 20030073910 A1 (hereinafter referred to as “Chance”).
Regarding claim 1, Chance, a trans-abdominal fetal oximetry device, teaches a method (includes a sensor system that includes a processor to perform functions; abstract) comprising:
receiving, by a processor, a physiological characteristic of a pregnant mammal (paragraph [0078]);
determining, by the processor, an impact of the physiological characteristic on a behavior of an optical signal projected into the abdomen of the pregnant mammal (paragraph [0078]); and
determining, by the processor, a calibration factor for the optical signal responsively to the impact (The calibration includes a variety of fetal conditions over a range of blood oxygenation and volume values of the fetal brain as well as a range of optical properties and thickness of the uterine and abdominal tissue layers; paragraph [0078]).
Regarding claim 3, Chance teaches wherein determining the calibration factor for the optical signal responsively to the impact comprises:
querying, by the processor, a database for a calibration factor that corresponds to the physiological characteristic (paragraphs [0052], [0091]).
Regarding claim 5, Chance teaches further comprising:
receiving, by the processor, a maternal detected electronic signal from a detector communicatively coupled to the processor, the maternal detected electronic signal corresponding to an optical signal emitted from the pregnant mammal's abdomen that has been detected by the detector and converted into the maternal detected electronic signal, the emitted optical signal being a portion of light projected, by a light source, into the pregnant mammal's abdomen (paragraphs [0077]-[0079]);
analyzing, by the processor, the maternal detected electronic signal, wherein the physiological characteristic of the pregnant mammal is determined responsively to the analysis (paragraphs [0077]-[0079]).
Regarding claim 6, Chance teaches further comprising:
storing, by the processor, the determined physiological characteristic and the calibration factor for the pregnant mammal in a database (paragraphs [0052], [0091]).
Regarding claim 8, Chance teaches wherein the physiological characteristic is intrinsic (paragraph [0078]).
Regarding claim 12, Chance teaches wherein the received physiological characteristic is a thickness of a muscle layer in the pregnant mammal's abdomen, further wherein the determination of the impact of the physiological characteristic on the behavior of the optical signal includes determining how much of the optical signal is absorbed by the muscle layer in the pregnant mammal's abdomen (paragraph [0078]).
Regarding claim 19, Chance teaches a method (includes a sensor system that includes a processor to perform functions; abstract) comprising:
receiving, by a processor, a maternal detected electronic signal from a detector communicatively coupled to the processor, the maternal detected electronic signal corresponding to an optical signal emitted from the pregnant mammal's abdomen that has been detected by the detector and converted into the maternal detected electronic signal, the emitted optical signal being a portion of light projected, by a light source, into the pregnant mammal's abdomen (paragraph [0077]-[0079]); and
analyzing, by the processor, the maternal detected electronic signal, to determine a physiological characteristic of the pregnant mammal (paragraph [0077]-[0079]); and
determining, by the processor, a calibration factor for the optical signal emanating from the pregnant mammal responsively to the analysis (paragraph [0077]-[0079]).
Regarding claim 42, Chance teaches a system comprising:
a memory that stores a set of instructions for execution by a processor that is communicatively coupled to the process (has a computer (which has a memory); paragraph [0076]); and
the processor (paragraph [0076]), which when executing the set of instructions stored in the memory is configured to:
receive a physiological characteristic of a pregnant mammal (paragraph [0077]-[0079]);
determine an impact of the physiological characteristic on a behavior of an optical signal projected into the abdomen of the pregnant mammal (paragraph [0077]-[0079]); and
determine a calibration factor for the optical signal responsively to the impact (paragraph [0077]-[0079]).
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 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.
Claim(s) 2 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chance, as applied to claims 1 and 11 above, and further in view of US 20110218413 A1 (hereinafter referred to as “Wang”).
Regarding claim 2, Chance does not explicitly teach teaches receiving, by the processor, a composite detected electronic signal from a detector communicatively coupled to the processor, the composite electronic signal corresponding to an optical signal emitted from the pregnant mammal's abdomen and a fetus contained therein that has been detected by the detector and converted into the composite detected electronic signal, the emitted optical signal being a portion of light projected, by a light source, into the pregnant mammal's abdomen and onto the fetus contained therein;
generating, by the processor, a fetal signal by isolating a portion of the composite detected electronic signal that corresponds to light that was incident upon the fetus;
generating, by the processor, a calibrated fetal signal by applying the calibration factor to the fetal signal;
determining, by the processor, a fetal hemoglobin oxygen saturation level using the calibrated fetal signal; and
facilitating, by the processor, provision of the fetal hemoglobin oxygen saturation level to a user.
However, Wang, a non-invasive fetal oximetry device/method, teaches receiving, by the processor, a composite detected electronic signal from a detector communicatively coupled to the processor, the composite electronic signal corresponding to an optical signal emitted from the pregnant mammal's abdomen and a fetus contained therein that has been detected by the detector and converted into the composite detected electronic signal, the emitted optical signal being a portion of light projected, by a light source, into the pregnant mammal's abdomen and onto the fetus contained therein (paragraphs [0009], [00051]-[0055], [0062]; claim 1);
generating, by the processor, a fetal signal by isolating a portion of the composite detected electronic signal that corresponds to light that was incident upon the fetus (paragraphs [0009], [00051]-[0055], [0062]; claim 1);
generating, by the processor, a calibrated fetal signal by applying the calibration factor to the fetal signal (paragraphs [0009], [00051]-[0055], [0062]; claim 1);
determining, by the processor, a fetal hemoglobin oxygen saturation level using the calibrated fetal signal (paragraphs [0009], [00051]-[0055], [0062]; claim 1); and
facilitating, by the processor, provision of the fetal hemoglobin oxygen saturation level to a user (paragraphs [0009], [00051]-[0055], [0062]; claim 1). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Chance, to use a composite signal in order to determine fetal oxygen saturation, as taught by Wang, because doing so allows the user to detect a physiological parameter of a fetus and mother.
Regarding claim 43, Chance does not explicitly teach wherein the processor, when executing the set of instructions is further configured to: receive a composite detected electronic signal from a detector communicatively coupled to the processor, the composite electronic signal corresponding to an optical signal emitted from the pregnant mammal's abdomen and a fetus contained therein that has been detected by the detector and converted into the composite detected electronic signal, the emitted optical signal being a portion of light projected, by a light source, into the pregnant mammal's abdomen and onto the fetus contained therein; generate a fetal signal by isolating a portion of the composite detected electronic signal that corresponds to light that was incident upon the fetus; generate a calibrated fetal signal by applying the calibration factor to the fetal signal; determine a fetal hemoglobin oxygen saturation level using the calibrated fetal signal; and facilitate provision of the fetal hemoglobin oxygen saturation level to a user.
However, Wang teaches wherein the processor, when executing the set of instructions is further configured to: receive a composite detected electronic signal from a detector communicatively coupled to the processor, the composite electronic signal corresponding to an optical signal emitted from the pregnant mammal's abdomen and a fetus contained therein that has been detected by the detector and converted into the composite detected electronic signal, the emitted optical signal being a portion of light projected, by a light source, into the pregnant mammal's abdomen and onto the fetus contained therein (paragraphs [0009], [00051]-[0055], [0062]; claim 1); generate a fetal signal by isolating a portion of the composite detected electronic signal that corresponds to light that was incident upon the fetus (paragraphs [0009], [00051]-[0055], [0062]; claim 1); generate a calibrated fetal signal by applying the calibration factor to the fetal signal (paragraphs [0009], [00051]-[0055], [0062]; claim 1); determine a fetal hemoglobin oxygen saturation level using the calibrated fetal signal (paragraphs [0009], [00051]-[0055], [0062]; claim 1); and facilitate provision of the fetal hemoglobin oxygen saturation level to a user (paragraphs [0009], [00051]-[0055], [0062]; claim 1). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Chance, to use a composite signal in order to determine fetal oxygen saturation, as taught by Wang, because doing so allows the user to detect a physiological parameter of a fetus and mother.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chance, as applied to claims 1 and 11 above, and further in view of US 20130190581 A1 (hereinafter referred to as “Al-Ali”).
Regarding claim 4, Chance does not explicitly teach further comprising:
receiving, by the processor, an indication of whether the fetal signal corresponds to pre-ductal or post-ductal blood; and
providing, by the processor, the indication of whether the fetal signal corresponds to pre-ductal or post-ductal blood when facilitating provision of the fetal hemoglobin oxygen saturation level to the user.
However, Al-Ali teaches receiving, by the processor, an indication of whether the fetal signal corresponds to pre-ductal or post-ductal blood (abstract; paragraphs [0052]-[0053], [0058]); and
providing, by the processor, the indication of whether the fetal signal corresponds to pre-ductal or post-ductal blood when facilitating provision of the fetal hemoglobin oxygen saturation level to the user (abstract; paragraphs [0052]-[0053], [0058]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Chance, to determine a post ductal or pre ductal blood parameter, as taught by Al-Ali because doing so provides an indication of congenital heart defects.
Conclusion
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/ABID A MUSTANSIR/Examiner, Art Unit 3791