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 Objections
Claim 9 is objected to because of the following informalities:
Claim 9, line 4: “the fetus” should be replaced with –a fetus–.
Claim 9, lines 7-8: “a fetus within the pregnant mammal’s abdomen” should be replaced with –the fetus–.
Appropriate correction is required.
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 9-15 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 9 recites “the housing is configured to remain positioned within the endocervical canal during fetal monitoring” in lines 4-5 and “the detector configured to detect light reflected from the pregnant mammal’s tissue and the fetus” in lines 9-10. First, it is unclear how the housing is configured to remain positioned within the endocervical canal during fetal monitoring while also detecting light reflected from the pregnant mammal’s tissue in light of the specification. The “endocervical canal” is understood by one of ordinary skill to correspond to the inner part of the cervix that forms a canal that connects the vagina to the uterus. In other words, the cervix comprises the endocervical canal. Figs. 2C-2D, 2G-2H depict the housing extended through and located within the endocervical canal. However, the above figures do not depict any intervening pregnant mammal tissue between the fetus and the housing, which makes it unclear whether the light is actually reflected from the pregnant mammal’s tissue while the housing is positioned within the endocervical canal. Second, it is unclear how “endocervical canal” should be interpreted in light of the specification. As noted above, the endocervical canal is the inner part of the cervix that connects the vagina to the uterus. However, the figures (e.g., Figs. 2A, 2C, 2E, and 2G) and specification (e.g., ¶ [0075]) depict the “endocervical canal 265” being different from the “cervix 270”. Instead, the reference number 265 appears to correspond to the vagina, which is separate from the cervix. The conflicting information creates confusion as to whether the recitations of “endocervical canal” actually correspond to the endocervical canal or the vagina. For the purposes of examination, the recitations of “endocervical canal” in lines 3 and 5, will be interpreted to be “vagina”.
Claim 9 recites “the housing is configured to remain positioned within the endocervical canal during fetal monitoring” in lines 4-5 and “the light source configured to project light of a plurality of waveforms into the endocervical canal” in lines 6-7, which are unclear in light of the specification. As noted above, the endocervical canal is the inner part of the cervix that connects the vagina to the uterus. The specification depicts embodiments in which the housing is within the endocervical canal of the cervix in Figs. 2C-2D and 2G-2H. However, the figures suggest that the light is transmitted directly to the fetus, without traveling into the endocervical canal, which conflicts with the claimed language. Therefore, it is unclear whether the light is projected into the canal. For the purposes of examination, the recitation of “the endocervical canal of the pregnant mammal” in lines 6-7 will be interpreted to be “tissue of the pregnant mammal”, which has support in at least Figs. 2A-2B, 2E-2F.
Claims 10-15 are rejected by virtue of their dependence from claim 9.
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.
Claims 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over US 6,175,751 B1 (Maizes), evidenced by US 5,217,013 A (Lewis), and in view of US 2020/0077929 (Missanelli)
With regards to claim 9, Maizes teaches a transcervical fetal oximetry probe (Col. 6, lines 53-60 depict an embodiment without a balloon in which the optical sensor is applied to the vagina to measure the oxygen levels of the fetus through the cervix, which indicates that the measurement is transcervical; also see Col. 4, lines 32-44 which indicates that the device is inserted into a body cavity adjacent to the uterus or uterine wall, wherein the body cavity includes the vagina) comprising: a light source and a detector (Fig. 1 and Col. 3, lines 5-26 depict an optical sensor 103 comprising an electro-optical light source 103A and a plurality of electro-optical light detectors 103B), the light source and the detector being sized and shaped to be inserted into an endocervical canal of a pregnant mammal and be positioned proximate the fetus (In view of the rejection under 35 U.S.C. §112(b) above, the recitation of “endocervical canal” is being interpreted to be “vagina”; Col. 6, lines 53-60 depict the optical sensor being applied to the vagina to measure the oxygen levels of the fetus through the cervix), wherein the light source and the detector are configured to remain positioned within the endocervical canal during fetal monitoring (In view of the rejection under 35 U.S.C. §112(b) above, the recitation of “endocervical canal” is being interpreted to be “vagina”; Col. 6, lines 53-60 depict the optical sensor being applied to the vagina to measure the oxygen levels of the fetus through the cervix, which indicates that the optical sensors remain in the vagina); the light source configured to project light of a plurality of wavelengths into the endocervical canal of the pregnant mammal to be incident on a fetus within the pregnant mammal's abdomen (In view of the rejection under 35 U.S.C. §112(b) above, the recitation of “endocervical canal” is being interpreted to be “tissue of the pregnant mammal”; Col. 6, lines 53-60 depict the optical sensor being applied to the vagina to measure the oxygen levels of the fetus through the cervix, which indicates that the light is projected into and through the cervix to be incident on the fetus; Col. 3, lines 5-27 indicate the optical sensors 103 are disclosed in US Pat. No. 5,217,013 (Lewis), which is incorporated by reference; Col. 5, lines 15-19 and Fig. 7 of Lewis disclose LEDs for producing different light wavelengths); the detector configured to detect light reflected from the pregnant mammal's tissue and the fetus (Col. 6, lines 53-60 depict the optical sensor being applied to the vagina to measure the oxygen levels of the fetus through the cervix, which indicates that the light reflected from the cervix and fetus are received by the detector of the optical sensor) and convert the detected light into a detected electronic signal that is communicated to an external processor configured to determine a level of fetal hemoglobin oxygen saturation with the detected electronic signal (Fig. 6 and Col. 4, lines 27-32 depict a control unit 110 that sends and receives signals from optical sensor 103 for determining and showing the fetal oxygen levels; also see Col. 5, lines 41-52 s; Col. 3, lines 5-11 indicate that the detectors 103B are electro-optical light detectors, which indicate they produce electronic signals).
The above embodiment of Col. 6, lines 53-60 of Maizes is silent regarding a housing configured to house the light source and the detector, the housing being sized and shaped to be inserted into an endocervical canal of a pregnant mammal and be positioned proximate the fetus, wherein the housing is configured to remain positioned within the endocervical canal during monitoring.
In the same field of endeavor of monitoring oxygen saturation of a fetus, Missanelli teaches a housing configured to house a light source and a detector (Fig. 2 and ¶ [0033] depict an intra-vaginal and intra-uterine oxy probe 100 including emitters 130a, 130B and sensor 125), the housing being sized and shaped to be inserted into an endocervical canal of a pregnant mammal and be positioned proximate the fetus (In view of the rejection under 35 U.S.C. §112(b) above, the recitation of “endocervical canal” is being interpreted to be “vagina”; ¶ [0036] indicates that the probe may be applied through a dilated cervix to monitor the fetus, which indicates that it is sized and shaped to also be inserted into a vagina), wherein the housing is configured to remain positioned within the endocervical canal (In view of the rejection under 35 U.S.C. §112(b) above, the recitation of “endocervical canal” is being interpreted to be “vagina”; Fig. 2 and ¶ [0036] depict the probe being applied through a dilated cervix, which indicates that the housing is sized and shaped such that it may also remain in the vagina). 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 the embodiment of Maizes to incorporate a housing configured to house the light source and the detector, the housing being sized and shaped to be inserted into an endocervical canal of a pregnant mammal and be positioned proximate the fetus, wherein the housing is configured to remain positioned within the endocervical canal as taught by Missanelli. The motivation would have been to provide a housing for protecting the optical sensor. Additionally or alternatively, it would have been the simple substitution of one known equivalent housing for another to obtain to obtain predictable results.
With regards to claim 12, the above combination teaches the detector is a first detector and the detected electronic signal is a first detected electronic signal (Fig. 1 and Col. 3, lines 5-26 depict an optical sensor 103 comprising an electro-optical light source 103A and a plurality of electro-optical light detectors 103B, which includes a first detector; Fig. 6 and Col. 4, lines 27-32 depict a control unit 110 that sends and receives signals from optical sensor 103 for determining and showing the fetal oxygen levels; Col. 3, lines 5-11 indicate that the detectors 103B are electro-optical light detectors, which indicate they produce electronic signals), the transcervical fetal oximetry probe further comprising a second detector configured to detect light reflected from the fetus and convert the detected light into a second detected electronic signal (Fig. 1 and Col. 3, lines 5-26 depict an optical sensor 103 comprising an electro-optical light source 103A and a plurality of electro-optical light detectors 103B, which includes a second detector; Fig. 6 and Col. 4, lines 27-32 depict a control unit 110 that sends and receives signals from optical sensor 103 for determining and showing the fetal oxygen levels; also see Col. 5, lines 41-52; Col. 3, lines 5-11 indicate that the detectors 103B are electro-optical light detectors, which indicate they produce electronic signals).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over US 6,175,751 B1 (Maizes), evidenced by US 5,217,013 A (Lewis), and in view of US 2020/0077929 (Missanelli), as applied to claim 9 above, and further in view of US 5,247,932 (Chung) (previously cited)
With regards to claim 10, the above combination is silent regarding a cord that extends from the housing and is configured to electrically couple the transcervical fetal oximetry probe to a power source and communicate signals including the detected electronic signal from the detector to the external processor.
In the same field of endeavor of fetal oximetry, Chung teaches a cord that extends from a housing (Fig. 3 depicts a cable 15 extending from sensor housing 4) and is configured to electrically couple the transcervical fetal oximetry probe to a power source (Fig. 3 and Col. 6, lines 43-53 depict a cable 15 containing wires which form a bus (corresponding to buses 208 and 209 of Figs. 1 and 2) for connecting electrode 32 to contact indicating unit in a remote oximeter monitor; Fig. 1 depicts 208, 209 connected to current generator 106 and voltage measuring unit 108 of pulse oximeter monitor 100; Col. 4, line 44 to Col. 5, line 7 depict 106 and/or 108 comprising a power supply) and communicate signals including the detected electronic signal from the detector to the external processor (Fig. 3, Col. 7, lines 3-15, and Col. 8, lines 31-38 depict a cable 15 containing wires coupled to units 6 and 8 and connected to N-200 pulse oximeter). 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 the above combination to incorporate a cord that extends from the housing and is configured to electrically couple the transcervical fetal oximetry probe to a power source and communicate signals including the detected electronic signal from the detector to the external processor as taught by Chung. The motivation would have been to provide structure for protecting the signal lines and allowing communication with processing elements.
Claim 11 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 6,175,751 B1 (Maizes), evidenced by US 5,217,013 A (Lewis), and in view of US 2020/0077929 (Missanelli), as applied to claim 9 above, and further in view of US 2017/0188920 A1 (Ray) (previously cited)
With regards to claim 11, The above combination is silent regarding a processor configured to pre-process the detected electronic signal prior to communication of the detected electronic signal to the external processor.
In the same field of endeavor of monitoring fetal oximetry, Ray teaches a processor configured to pre-process the detected electronic signal prior to communication of the detected electronic signal to an external processor (Fig. 2A and ¶¶ [0073]-[0075] depicts a receiver 145 configured to receive signals and/or data from fetal hemoglobin probe 115, NIRS adult hemoglobin probe 125, and pulse oximetry probe 130, and configured to pre-press the received signals prior to providing the signals to the computer 150). 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 the system of the above combination to incorporate a processor configured to pre-process the detected electronic signal prior to communication of the detected electronic signal to an external processor as taught by Ray. The motivation would have been to improve SNR, amplify a received signal, and/or to make the signals compatible with the external processor (¶ [0074] of Ray).
With regards to claim 14, the above combination is silent regarding whether the housing further comprises a power supply.
In the same field of endeavor of monitoring fetal hemoglobin oxygen saturation, Ray teaches a housing comprising a power supply (Figs. 2B-2E and ¶¶ [0078], [0087]-[0088] depict a housing 102 comprising a power supply 160; ¶ [0016] discloses the power source being adapted for providing electrical power to the light sources, detector, and transceiver). 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 the housing of the above combination to comprise a power supply as taught by Ray. The motivation would have been to provide onboard electrical power to the light sources and detector.
With regards to claim 15, the above combination is silent regarding whether the housing further comprises a transceiver.
In the same field of endeavor of monitoring fetal hemoglobin oxygen saturation, Ray teaches a housing comprising a transceiver (Figs. 2B-2E depict a housing 102 comprising a transceiver 107; ¶ [0095] depict the transceiver 107 being used for communicating the electronic signal to external equipment). 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 the housing of the above combination to incorporate a transceiver as taught by Ray. The motivation would have been to allow for the probe to communicate with other equipment in a wired or wireless fashion (¶ [0095] of Ray).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over r US 6,175,751 B1 (Maizes), evidenced by US 5,217,013 A (Lewis), and in view of US 2020/0077929 (Missanelli) and US 5,247,932 (Chung) (previously cited), as applied to claim 10 above, and further in view of US 2004/0153008 A1 (Sharf) (previously cited).
With regards to claim 13, the above combination is silent regarding whether the cord is configured to facilitate extraction of the transcervical fetal oximetry probe from the pregnant mammal's endocervical canal.
In a system relevant to the problem of extracting a probe from a birth canal, Sharf teaches a cord configured to facilitate extraction of a probe from the pregnant mammal's endocervical canal (¶ [0157] and Fig. 6C depict a tube 630 being used to pull a housing 616 from a birth canal, allowing removal of the device from the birth canal). 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 the cable of the above combination, based on the teachings of Sharf, such that it is configured to facilitate extraction of the transcervical fetal oximetry probe from the pregnant mammal's endocervical canal. The motivation would have been to allow for the probe to be easily removed.
Response to Arguments
Claim Objections
There are new grounds of claim objections necessitated by the claim amendments filed 03/09/2026.
Claim Rejections – 35. U.S.C. §112
There are new grounds of claim rejections under 35 U.S.C. §112(b) necessitated by the claim amendments filed 03/09/2026.
Prior Art Rejections
There are new grounds of rejections necessitated by the claim amendments filed 03/09/2026. Applicant’s arguments with respect to claim 9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. See the above rejection of claim 9 over US 6,175,751 B1 (Maizes), evidenced by US 5,217,013 A (Lewis), and in view of US 2020/0077929 (Missanelli). Applicant’s arguments regarding the dependent claims are not persuasive because the above combination in the new ground of rejections does not have the deficiencies of previously-applied Chung.
Conclusion
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.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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