DETAILED ACTION
Summary
Claims 1-20 are pending in the application. Claim 10 has been withdrawn from further consideration. Claims 7-9, and 17 rejected under 35 U.S.C. 112(b). Claims 5-6, 15-17, and 20 rejected under 35 U.S.C. 101. Claims 1-3, 7-8, and 11-12 are rejected under 35 U.S.C. 102(a)(1). Claims 4-6, 9, 13-20 are rejected under 35 U.S.C 103.
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 .
Election/Restrictions
Claim 10 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/31/2026.
Applicant’s election without traverse of Invention I in the reply filed on 3/31/2026 is acknowledged.
Claim Objections
Claims 2 and 7 objected to because of the following informalities:
Claim 2 recites “cervical dilation” in lines 2-3. It should recite “the cervical dilation”.
Claim 7 recites “the cup and imaging unit” in line 1. It should recite “the cup and the imaging unit”.
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(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “imaging unit” in claims 1 and 11, and “computing device” in claims 2 and 11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The limitations will be interpreted as follows:
“an imaging unit” will be interpreted as a camera, or equivalents thereof, consistent with [0027] of the specification.
“a computing device” will be interpreted as a processor running software, or equivalents thereof, consistent with [0035] of the specification.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 7-9, and 17 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 7 recites “cervical dilation of a patient” in line 2. It is not clear if this is referring to the cervical dilation of the patient previously set forth, or if this is referring to a different cervical dilation of a different patient. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 8 recites “a patient” in line 2. It is not clear if this is referring to a new patient, or if this is referring to the patient previously set forth. Clarification is required. For the purposes of examination, the latter definition will be used.
Claim 17 recites “wherein the distance is determined is measured and identified by the computing device”. It is not clear if “determining” the distance is a separate step than measuring and identifying the distance, or if measuring and identifying the distance is clarifying what it means for the distance to be determined. Clarification is required. For the purposes of examination, the latter definition will be used.
All claims dependent from the above claims rejected under 35 USC 112(b) are also rejected, as the limitations of the dependent claims fail to cure the deficiencies identified above.
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.
Claims 5-6, 15-17, and 20 rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 5-6, 15-17, and 20 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 5 recites “wherein the cervix is illuminated by the light source” in lines 2-3. This is positively reciting the human body, as the cervix needs to be a part of the system and be illuminated to read on the claim. The Examiner recommends amending the claim to recite “wherein the light source is configured to illuminate the cervix” to make it clear the cervix is not a part of the system.
Claim 6 recites “the imaging unit captures the visual data of the cervix, which is illuminated by the light source”. This is positively reciting the human body, as the imaging unit must capture imaging data of the cervix which is illuminated by the light source. The Examiner recommends amending the claim to use “configured to” language to make it clear the cervix is not a part of the system.
Claim 15 recites “the imaging unit captures the visual data of the cervix, which is illuminated by the light source”. This is positively reciting the human body, as the imaging unit must capture imaging data of the cervix which is illuminated by the light source. The Examiner recommends amending the claim to use “configured to” language to make it clear the cervix is not a part of the system.
Claim 20 recites “the imaging unit captures the visual data of the cervix”. This is positively reciting the human body, as the imaging unit must capture imaging data of the cervix. The Examiner recommends amending the claim to use “configured to” language to make it clear the cervix is not a part of the system.
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, 7-8, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stern-Cohen et al. (WO 2017/168421 A2).
Regarding Claim 1, Stern-Cohen discloses a system (Abstract), comprising:
a cup (Fig. 4C, 431) (Pg. 30, lines 1-7), comprising:
a first end (Fig. 4C, 431, bottom portion), and a second end opposing the first end (Fig. 4C, 431, top portion) (Pg. 30, lines 1-7); and
a first opening positioned at the first end (Fig. 4C, 431, bottom portion has an opening as it is “cup shaped”, and therefore would have an opening on the distal end), and a second opening positioned at the second end (Fig. 4C, 431, top portion, there is a cable coming out of the top part of the cup portion, which means there must be a second opening there which allows the cable to exit. The cup is also a “hollow lumen” which suggests there are 2 openings at both ends) (Pg. 30, lines 1-7); and
an imaging unit within the cup (Fig. 4, 451) (Pg. 30, lines 1-7), the imaging unit configured to capture visual data through the first opening to measure cervical dilation of a patient (Pg. 30, lines 1-7)+(Pg. 15, lines 12-21).
Regarding Claim 2, Stern-Cohen teaches the invention as claimed. Stern-Cohen further teaches a computing device (Pg. 7, lines 3-10) communicably coupled to the imaging unit configured to process the data to measure cervical dilation of the patient (Pg. 2, lines 19-21)+(Pg. 4, lines 1-2).
Regarding Claim 3, Stern-Cohen teaches the invention as claimed. Stern-Cohen further teaches a light source (Pg. 20, lines 3-5) (illuminator) configured to direct light through the first opening (Pg. 20, lines 3-5) (as the imager and the illuminator are part of the same system, one of ordinary skill would recognize that the illuminator would direct the light in the same area as the images (i.e. through the opening)).
Regarding Claim 7, Stern-Cohen teaches the invention substantially as claimed. Stern-Cohen further teaches wherein the cup and imaging unit are part of an intravaginal monitoring device for measuring cervical dilation of a patient (Pg. 2, lines 17-25)+(Pg. 2, lines 1-2).
Regarding Claim 8, Stern-Cohen teaches the invention substantially as claimed. Stern-Cohen further teaches the device is further configured for measuring effacement of a patient (Pg. 4, lines 1-2).
Regarding Claim 11, Stern-Cohen discloses a system (Abstract), comprising:
a cup (Fig. 4C, 431) (Pg. 30, lines 1-7), comprising:
a first end (Fig. 4C, 431, bottom portion), and a second end opposing the first end (Fig. 4C, 431, top portion) (Pg. 30, lines 1-7); and
a first opening positioned at the first end (Fig. 4C, 431, bottom portion has an opening as it is “cup shaped”, and therefore would have an opening on the distal end), and a second opening positioned at the second end (Fig. 4C, 431, top portion, there is a cable coming out of the top part of the cup portion, which means there must be a second opening there which allows the cable to exit. The cup is also a “hollow lumen” which suggests there are 2 openings at both ends) (Pg. 30, lines 1-7); and
an imaging unit within the cup (Fig. 4, 451) (Pg. 30, lines 1-7), the imaging unit configured to capture visual data through the first opening to measure cervical dilation of a patient (Pg. 30, lines 1-7)+(Pg. 15, lines 12-21)
a computing device (Pg. 7, lines 3-10) communicably coupled to the imaging unit configured to process the data to measure cervical dilation of the patient (Pg. 2, lines 19-21)+(Pg. 4, lines 1-2).
Regarding Claim 12, Stern-Cohen teaches the invention as claimed. Stern-Cohen further teaches a light source (Pg. 20, lines 3-5) (illuminator) configured to direct light through the first opening (Pg. 20, lines 3-5) (as the imager and the illuminator are part of the same system, one of ordinary skill would recognize that the illuminator would direct the light in the same area as the images (i.e. through the opening)).
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.
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 4-6, and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Stern-Cohen in view of Mansour et al. (U.S PGPub 2005/0049509 A1).
Regarding Claim 4, Stern-Cohen teaches the invention substantially as claimed. While Stern-Cohen teaches the imager determines a distance between the imager and the cervix (Pg. 37, lines 16-19), Stern Cohen fails to explicitly teach a proximity sensor within the cup, wherein the sensor is configured to capture a distance between the imaging unit and a cervix of the patient.
Mansour teaches a probe for monitoring the cervix (Abstract). This probe contains a camera (Fig. 12, 506) and a proximity sensor (Fig. 12, 602) which is configured to capture a distance between the imaging unit and a cervix of the patient [0131]-[0132].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Stern-Cohen to include a proximity sensor, as taught by Mansour, because this allows for greater accuracy in the measurement of the cervix, as recognized by Mansour [0131]. One of ordinary skill would recognize that, as the imager of Stern-Cohen is within the cup, and the rangefinder of Mansour is on the imager [0131]-[0132], the combined system would result in the proximity sensor being with the cup.
Regarding Claim 5, the combination teaches the invention as claimed. Stern-Cohen further teaches a light source (Pg. 20, lines 3-5) (illuminator) configured to direct light through the first opening (Pg. 20, lines 3-5) (as the imager and the illuminator are part of the same system, one of ordinary skill would recognize that the illuminator would direct the light in the same area as the images (i.e. through the opening)), and wherein the cervix is illuminated by the light source (Pg. 26, lines 5-8)+(Pg. 20, lines 3-10 & lines 20-29) (As the illuminator is on the imager, it would illuminate what the imager is imaging (e.g. the cervix)).
Regarding Claim 6, the combination teaches the invention substantially as claimed. Stern-Cohen further teaches wherein the cup, the imaging unit (Pg. 30, lines 1-7), are configured to be inserted together into a vaginal canal of the patient (Fig. 1A, 103) (Pg. 14, lines 24-26) and oriented such that the imaging unit captures visual data of the cervix, which is illuminated by the light source (Fig. 1A, 107) (Pg. 15, lines 12-21).
Stern-Cohen fails to explicitly teach the proximity sensor.
Mansour teaches a probe for monitoring the cervix (Abstract). This probe contains a camera (Fig. 12A, 506) and a proximity sensor (Fig. 12A, 602) which is configured to capture a distance between the imaging unit and a cervix of the patient [0131]-[0132].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Stern-Cohen to include a proximity sensor, as taught by Mansour, because this allows for greater accuracy in the measurement of the cervix, as recognized by Mansour [0131]. One of ordinary skill would recognize that, as the imager of Stern-Cohen is within the cup, and the rangefinder of Mansour is on the imager [0131]-[0132], the combined system would result in the proximity sensor being with the cup and inserted along with the cup and imager.
Regarding Claim 13, Stern-Cohen teaches the invention substantially as claimed. While Stern-Cohen teaches the imager determines a distance between the imager and the cervix (Pg. 37, lines 16-19), Stern Cohen fails to explicitly teach a proximity sensor within the cup,.
Mansour teaches a probe for monitoring the cervix (Abstract). This probe contains a camera (Fig. 12, 506) and a proximity sensor (Fig. 12A, 602) [0131]-[0132].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Stern-Cohen to include a proximity sensor, as taught by Mansour, because this allows for greater accuracy in the measurement of the cervix, as recognized by Mansour [0131]. One of ordinary skill would recognize that, as the imager of Stern-Cohen is within the cup, and the rangefinder of Mansour is on the imager [0131]-[0132], the combined system would result in the proximity sensor being with the cup.
Regarding Claim 14, the combination of references teaches the invention substantially as claimed. Mansour further teaches wherein the sensor is positioned adjacent to the imaging unit.
Mansour further teaches the sensor is positioned adjacent to the imaging unit (Fig. 12A, 602 is adjacent 504+506) [0131]-[0132].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Stern-Cohen to include a proximity sensor adjacent to the imaging unit, as taught by Mansour, because this allows for greater accuracy in the measurement of the cervix, as recognized by Mansour [0131].
Regarding Claim 15, the combination teaches the invention substantially as claimed. Stern-Cohen further teaches wherein the cup, the imaging unit (Pg. 30, lines 1-7), are configured to be inserted together into a vaginal canal of the patient (Fig. 1A, 103) (Pg. 14, lines 24-26) and oriented such that the imaging unit captures visual data of the cervix, which is illuminated by the light source (Fig. 1A, 107) (Pg. 15, lines 12-21).
Stern-Cohen fails to explicitly teach the proximity sensor.
Mansour teaches a probe for monitoring the cervix (Abstract). This probe contains a camera (Fig. 12A, 506) and a proximity sensor (Fig. 12A, 602) which is configured to capture a distance between the imaging unit and a cervix of the patient [0131]-[0132].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Stern-Cohen to include a proximity sensor, as taught by Mansour, because this allows for greater accuracy in the measurement of the cervix, as recognized by Mansour [0131]. One of ordinary skill would recognize that, as the imager of Stern-Cohen is within the cup, and the rangefinder of Mansour is on the imager [0131]-[0132], the combined system would result in the proximity sensor being with the cup and inserted along with the cup and imager.
Regarding Claim 16, Stern-Cohen teaches the invention substantially as claimed. While Stern-Cohen teaches the imager determines a distance between the imager and the cervix (Pg. 37, lines 16-19), Stern Cohen fails to explicitly teach wherein the proximity sensor is configured to capture a distance between the imaging unit and a cervix of the patient.
Mansour teaches a probe for monitoring the cervix (Abstract). This probe contains a camera (Fig. 12, 506) and a proximity sensor (Fig. 12, 602) which is configured to capture a distance between the imaging unit and a cervix of the patient [0131]-[0132].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Stern-Cohen to include a proximity sensor, as taught by Mansour, because this allows for greater accuracy in the measurement of the cervix, as recognized by Mansour [0131].
Regarding Claim 17, the combination of reference teaches the invention substantially as claimed. Stern-Cohen fails to explicitly teach wherein the distance is determined is measured and identified by the computing device.
Mansour further teaches that the distance is determined (i.e. measure and identified) by a processor (a computing device) [0131]-[0132].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Stern-Cohen to include a proximity sensor, as taught by Mansour, because this allows for greater accuracy in the measurement of the cervix, as recognized by Mansour [0131].
Regarding Claim 18, Stern-Cohen teaches the invention substantially as claimed. While Stern-Cohen teaches the imager determines a distance between the imager and the cervix (Pg. 37, lines 16-19), Stern Cohen fails to explicitly teach a proximity sensor within the cup,.
Mansour teaches a probe for monitoring the cervix (Abstract). This probe contains a camera (Fig. 12, 506) and a proximity sensor (Fig. 12A, 602) [0131]-[0132].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Stern-Cohen to include a proximity sensor, as taught by Mansour, because this allows for greater accuracy in the measurement of the cervix, as recognized by Mansour [0131]. One of ordinary skill would recognize that, as the imager of Stern-Cohen is within the cup, and the rangefinder of Mansour is on the imager [0131]-[0132], the combined system would result in the proximity sensor being with the cup.
Regarding Claim 19, the combination of references teaches the invention substantially as claimed. Mansour further teaches wherein the sensor is positioned adjacent to the imaging unit.
Mansour further teaches the sensor is positioned adjacent to the imaging unit (Fig. 12A, 602 is adjacent 504+506) [0131]-[0132].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Stern-Cohen to include a proximity sensor adjacent to the imaging unit, as taught by Mansour, because this allows for greater accuracy in the measurement of the cervix, as recognized by Mansour [0131].
Regarding Claim 20, the combination teaches the invention substantially as claimed. Stern-Cohen further teaches wherein the cup, the imaging unit (Pg. 30, lines 1-7), are configured to be inserted together into a vaginal canal of the patient (Fig. 1A, 103) (Pg. 14, lines 24-26) and oriented such that the imaging unit captures visual data of the cervix (Fig. 1A, 107) (Pg. 15, lines 12-21).
Stern-Cohen fails to explicitly teach the proximity sensor.
Mansour teaches a probe for monitoring the cervix (Abstract). This probe contains a camera (Fig. 12A, 506) and a proximity sensor (Fig. 12A, 602) which is configured to capture a distance between the imaging unit and a cervix of the patient [0131]-[0132].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Stern-Cohen to include a proximity sensor, as taught by Mansour, because this allows for greater accuracy in the measurement of the cervix, as recognized by Mansour [0131]. One of ordinary skill would recognize that, as the imager of Stern-Cohen is within the cup, and the rangefinder of Mansour is on the imager [0131]-[0132], the combined system would result in the proximity sensor being with the cup and inserted along with the cup and imager.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Stern-Cohen in view of Eltorai (U.S PGPub 2023/0363696 A1).
Regarding Claim 9, Stern-Cohen teaches the invention substantially as claimed. While Stern Cohen teaches identifying the fetal head (Pg. 21, lines 14-19) and the position of the fetal membrane (Pg. 22, lines 5-19) Stern-Cohen fails to explicitly teach wherein the device is further configured for measuring fetal position within the patient.
Eltorai teaches a system for monitoring labor progression (Abstract). This system determines the position of the fetus [0003]+[0032] using an optical sensor (Fig. 1, 120) [0015].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Stern-Cohen to measure fetal position within the patient, as taught by Eltorai, because this provides a safer, more precise, method of labor monitoring, thereby increasing the quality of care of the patient, as recognized by Eltorai [0002].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sliwa et al. (U.S Patent 6,039,701) which teaches a method for measuring a cervical diameter.
Ziarno et al. (U.S PGPub 2011/0190579 A1), which teaches an intravaginal monitoring device.
Turan (WO 2025/090051 A1), which teaches a probe for using artificial intelligence to monitor labor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN D MATTSON whose telephone number is (408)918-7613. The examiner can normally be reached Monday - Friday 9 AM - 5 PM PST.
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/SEAN D MATTSON/Primary Examiner, Art Unit 3798
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