DETAILED ACTION
Claims 1-19 are hereby under examination.
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 statement (IDS) submitted on 08/24/2025 is being considered by the examiner.
Claim Objections
Claims 6, 16, 18, and 19 are objected to because of the following informalities:
Regarding claim 6, line 4 recites “the risk”, however it appears it should read –a risk—(emphasis added).
Regarding claim 16, line 3 recites “the risk”, however it appears it should read –a risk—(emphasis added).
Regarding claim 18, line 1 recites “the disposable cervical device”, however it appears it should read –the cervical device—(emphasis added).
Regarding claim 19, line 1 recites “the disposable cervical device”, however it appears it should read –the cervical device—(emphasis added).
Claim Interpretation - 35 USC § 112(f)
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:
Claim 1: The claim limitation “disposable cervical device … measures attributes of a cervix …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “device” coupled with functional language “measures attributes of a cervix …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “device”.
Claim 11: The claim limitation “measuring aspects of a cervix of the pregnant woman with the cervical device” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “device” coupled with functional language “measuring aspects of a cervix of the pregnant woman” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “device”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“home-based screening kit … miniature inbuilt camera … ultrasound patch … sensor …”, or equivalents thereof, as described in para. [0022] of the disclosure filed on 02/17/2025.
“home-based screening kit … miniature inbuilt camera … ultrasound patch … sensor …”, or equivalents thereof, as described in para. [0022] of the disclosure filed on 02/17/2025.
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 § 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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Analysis of independent claims 1 and 11:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a system, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Claim 11 is directed to a method, which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1 and 11 recite an abstract idea. In particular, the claim recites the following:
Provide an indication of immediate onset of labor or risk of onset of labor within a predetermined time frame.
These elements required of claims 1 and 11 are drawn to an abstract idea since (1) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Providing an indication of immediate onset of labor within a predetermined time frame is a mental process that can be practically performed in the human mind, with the aid of pen and paper. For example, a person with ordinary skill in the art can mentally determine and provide an indication of immediate onset of labor or risk of labor based on analyzing collected data on a piece of paper. There is nothing to suggest an undue level of complexity in the analyzing and providing an indication steps.
Prong Two: Claims 1 and 11 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “a smartphone application …” (claim 1), “transmitting the measurements to a smartphone application …” (claim 11)), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “disposable cervical device …” (claim 1), “instructing the pregnant woman to self-insert a cervical device … measuring aspects of a cervix of the pregnant woman with the cervical device …” (claim 11)); the post-solution activity of: (e.g. N/A); using generic data-outputting components (e.g. N/A)).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, “a disposable cervical device configured to be self-inserted by the pregnant woman, the cervical device measures attributes of a cervix of the pregnant woman” is well-understood, routine, and conventional, as disclosed by Schentag et al. (US 20130225922 A1) – para. [0032], para. [0056].
Further, “a smartphone application” does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 11 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to necessary pre-solution data gathering steps, which merely facilitate the abstract idea.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of the dependent claims:
Claims 2-10 and 12-19 depend from the independent claim. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“the smartphone application is further configured to analyze patient parameters including gestational age, cervical length, cervical dilatation, presence of fFN, fetal heart rate, and previous risk history to assess the risk of preterm labor” (claim 6), “the indication of labor onset or risk thereof is based on a combination of detected presence of fFN, cervical shortening, and cervical dilatation” (claim 8), “the disposable cervical device is configured for use by a high-risk pregnant mother with a previous history of miscarriages or preterm births or a pregnant mother likely to be in false labor” (claim 9), “the disposable cervical device is configured for use by a term mother for an initial assessment of timing of labor and delivery” (claim 10), “the indication of labor onset or risk thereof includes an assessment of fetal distress based on fetal heart rate and cervical conditions” (claim 14), “analyzing patient parameters including gestational age, cervical length, cervical dilatation, presence of fFN, fetal heart rate, and previous risk history to assess the risk of preterm labor with the smartphone application” (claim 16), “the indication of labor onset or risk thereof is based on a combination of detected presence of fFN, cervical shortening, and cervical dilatation” (claim 17), “the disposable cervical device is configured for use by a high-risk pregnant mother with a previous history of miscarriages or preterm births or a pregnant mother likely to be in false labor” (claim 18), “the disposable cervical device is configured for use by a term mother for an initial assessment of timing of labor and delivery” (claim 19)),
Further describe the pre-solution activity (or the structure used for such activity) (“the cervical device includes a miniature camera for visualizing cervical dilation” (claim 2), “the cervical device includes an ultrasound patch for measuring cervical length and detecting fetal heart rate” (claim 3), “the cervical device includes a sensor for detecting the presence of Fetal Fibronectin (fFN) in cervical secretion” (claim 4), “the cervical device has a form factor of a disposable tampon” (claim 5), “measuring aspects of the cervix includes capturing images of the cervix, measuring cervical length, detecting fetal heart rate, and detecting the presence of fFN in cervical secretions using the cervical device” (claim 12), “the cervical device has a form factor of a disposable tampon” (claim 15)),
Further describe the computer implementation (“the smartphone application is further configured to communicate with a remote physician to provide an assessment based on the received data” (claim 7), “communicating the analyzed data to a remote physician for assessment and advice” (claim 13)), and
Further describe the post-solution activity (N/A) (recited at a high level of generality).
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional.
For example, “a miniature camera for visualizing cervical dilation …” is well-understood, routine, and conventional, as disclosed by Schentag et al. (US 20130225922 A1) – para. [0034], para. [0056].
For example, “an ultrasound patch for measuring cervical length and detecting fetal heart rate” is well-understood, routine, and conventional, as disclosed by Hall et al. (US 20100222679 A1) - para. [0055-0056] and Siker et al. (US 5425362 A) - col. 3, lines 48-51.
For example, “a sensor for detecting the presence of Fetal Fibronectin (fFN) in cervical secretion” is well-understood, routine, and conventional, as disclosed by Schentag et al. (US 20130225922 A1) – para. [0039], para. [0117].
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subjection matter. Claims 1-19 are rejected.
Claim Rejections - 35 USC § 102
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 1-2, 4-5, 7, 9-15, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schentag et al. (US 20130225922 A1), hereinafter referred to as Schentag.
The claims are generally directed towards a system for detecting the onset of labor in a pregnant woman, comprising: a disposable cervical device configured to be self-inserted by the pregnant woman, the cervical device measures attributes of a cervix of the pregnant woman; and a smartphone application configured to receive data from the cervical device and to provide an indication of immediate onset of labor or risk of onset of labor within a predetermined time frame.
Regarding claim 1, Schentag discloses a system for detecting the onset of labor in a pregnant woman (Abstract), comprising:
a disposable cervical device configured to be self-inserted by the pregnant woman, the cervical device measures attributes of a cervix of the pregnant woman (Fig. 14, element 200, para. [0032], “retrievable implantation … in vivo monitoring of an individual … configured to be implanted in … the vagina … capsule shaped …”, para. [0056], “image capture device … cervix of the individual …”, para. [0063], para. [0069], para. [0117]); and
a smartphone application configured to receive data from the cervical device and to provide an indication of immediate onset of labor or risk of onset of labor within a predetermined time frame (para. [0052], para. [0056], “capture an image of the cervix … monitor the dilation of the cervix of the individual during labor”, para. [0057], “retrievable device may have a transmitter and/or a receiver … transmit signals received from the sensor and/or image capture device … external device for monitoring by an operator …”, para. [0061], “remote receiver … a mobile phone or handheld computer with storage and communication features …”, para. [0063], “data captured by the capsule may be transmitted to a PC or to a patient worn device …”, para. [0095], “display of collected data … monitoring their condition …”).
Regarding claim 2, Schentag discloses the system of claim 1, wherein the cervical device includes a miniature camera for visualizing cervical dilation (para. [0034], “image capture device … camera …”, para. [0056], “capture images of the cervix of the individual … monitor the dilation of the cervix of an individual during labor …”).
Regarding claim 4, Schentag discloses the system of claim 1, wherein the cervical device includes a sensor for detecting the presence of Fetal Fibronectin (fFN) in cervical secretion (para. [0039-0041], “analyte sensor …”, para. [0117], “fetal fibronectin”).
Regarding claim 5, Schentag discloses the system of claim 1, wherein the cervical device has a form factor of a disposable tampon (Fig. 14, element 200, para. [0032], “retrievable implantation … in vivo monitoring of an individual … configured to be implanted in … the vagina … capsule shaped …”, para. [0037], “fitting … string … aid in the retrieval of the device …”).
Regarding claim 7, Schentag discloses the system of claim 1, wherein the smartphone application is further configured to communicate with a remote physician to provide an assessment based on the received data (para. [0056], “medical professional may monitor the dilation of the cervix …”, para. [0068], “remote healthcare provider examination and monitoring of vaginal and cervical status …”).
Regarding claim 9, Schentag discloses the system of claim 1.
In regard to the limitation of “wherein the disposable cervical device is configured for use by a high-risk pregnant mother with a previous history of miscarriages or preterm births or a pregnant mother likely to be in false labor”, it is considered an intended use of the claimed device. Such a limitation does not further limit the structure of the claimed device. There is no recitation in the claim what structural limitation causes the device to be configured for use by a high-risk pregnant mother with a previous history of miscarriages or preterm births or a pregnant mother likely to be in false labor. As Schentag teaches the disposable cervical device and smartphone application, as recited above, it is considered reading on the limitation of “wherein the disposable cervical device is configured for use by a high-risk pregnant mother with a previous history of miscarriages or preterm births or a pregnant mother likely to be in false labor”. For the above consideration, see MPEP § 2114.II: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding claim 10, Schentag discloses the system of claim 1.
In regard to the limitation of “wherein the disposable cervical device is configured for use by a term mother for an initial assessment of timing of labor and delivery”, it is considered an intended use of the claimed device. Such a limitation does not further limit the structure of the claimed device. There is no recitation in the claim what structural limitation causes the device to be configured for use by a term mother for an initial assessment of timing of labor and delivery. As Schentag teaches the disposable cervical device and smartphone application, as recited above, it is considered reading on the limitation of “wherein the disposable cervical device is configured for use by a term mother for an initial assessment of timing of labor and delivery”. For the above consideration, see MPEP § 2114.II: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding claim 11, Schentag discloses a method for detecting the onset of labor in a pregnant woman (Abstract, para. [0011]), the method comprising:
instructing the pregnant woman to self-insert a cervical device (para. [0032], “retrievable implantation … in vivo monitoring of an individual … configured to be implanted in … the vagina … capsule shaped …”, para. [0055], “implantation may be implantation in a body orifice …”, para. [0069], “adjustment of the capsules positioning by the patient”);
measuring aspects of a cervix of the pregnant woman with the cervical device (para. [0056], “image capture device … cervix of the individual …”, para. [0070], para. [0117]);
transmitting the measurements to a smartphone application (para. [0057], “retrievable device may have a transmitter and/or a receiver … transmit signals received from the sensor and/or image capture device … external device for monitoring by an operator …”, para. [0061], “remote receiver … a mobile phone or handheld computer with storage and communication features …”); and
analyzing the transmitted data with the smartphone application to provide an indication of labor onset or risk thereof (para. [0056], “monitor the dilation of the cervix of the individual during labor …”, para. [0057], “external device for monitoring by an operator …”, para. [0095], “display of collected data … monitoring their condition …”).
Regarding claim 12, Schentag discloses the method of claim 11, wherein measuring aspects of the cervix includes capturing images of the cervix (para. [0034], “image capture device … camera …”, para. [0056], “capture images of the cervix of the individual … monitor the dilation of the cervix of an individual during labor …”), measuring cervical length (para. [0056], “monitor the dilation of the cervix …”), detecting fetal heart rate (para. [0085], “sensing of … heart rate measures from … fetus …”), and detecting the presence of fFN in cervical secretions using the cervical device (para. [0039-0041], “analyte sensor …”, para. [0117], “fetal fibronectin”).
Regarding claim 13, Schentag discloses the method of claim 11, further comprising communicating the analyzed data to a remote physician for assessment and advice (para. [0056], “medical professional may monitor the dilation of the cervix …”, para. [0068], “remote healthcare provider examination and monitoring of vaginal and cervical status …”).
Regarding claim 14, Schentag discloses the method of claim 11, wherein the indication of labor onset or risk thereof includes an assessment of fetal distress based on fetal heart rate and cervical conditions (para. [0056], “medical professional may monitor the dilation of the cervix …”, para. [0068], “remote healthcare provider examination and monitoring of vaginal and cervical status …”, para. [0085], “heart rate measures from … fetus”).
Regarding claim 15, Schentag discloses the method of claim 11, wherein the cervical device has a form factor of a disposable tampon (Fig. 14, element 200, para. [0032], “retrievable implantation … in vivo monitoring of an individual … configured to be implanted in … the vagina … capsule shaped …”, para. [0037], “fitting … string … aid in the retrieval of the device …”).
Regarding claim 19, Schentag discloses the method of claim 11, wherein the disposable cervical device is configured for use by a term mother for an initial assessment of timing of labor and delivery (para. [0056], “capture images of the cervix of the individual … monitor the dilation of the cervix of an individual during labor …”).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Schentag et al. (US 20130225922 A1), hereinafter referred to as Schentag as applied to claim 1 above, and further in view of Hall et al. (US 20100222679 A1), hereinafter referred to as Hall, in view of Siker et al. (US 5425362 A), hereinafter referred to as Siker.
Regarding claim 3, Schentag discloses the system of claim 1.
However, Schentag does not explicitly disclose wherein the cervical device includes an ultrasound patch for measuring cervical length.
Hall teaches an analogous system for detecting the onset of labor comprising a disposable cervical device to measure attributes of a cervix of a pregnant woman and an application configured to receive data and provide an indication of labor (Abstract, Fig. 1, Fig. 5, para. [0007], para. [0042], para. [0056]). Hall further teaches the cervical device includes an ultrasound patch for measuring cervical length (para. [0055-0056]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by Schentag to additionally include an ultrasound path for measuring cervical length, as taught by Schentag. This is because Schentag teaches measuring cervical length provides an additional parameter for determining risk of preterm delivery, thereby improving the system of Schentag in a predictable manner (para. [0056]).
However, modified Schentag does not explicitly disclose the ultrasound patch also detects fetal heart rate.
Siker teaches an analogous disposable cervical device for measuring attributes of a cervix (Abstract, Fig. 1, col. 2, line 39 – col. 3, line 25). Siker further teaches the cervical device comprises an ultrasound patch for detecting fetal heart rate (col. 3, lines 48-51). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and ultrasound path taught by modified Schentag to additionally detect fetal heart rate, as taught by Siker. Additionally measuring the fetal heart rate via the ultrasound patch would yield the predictable result of measuring additional fetal parameters for determining fetal distress, as taught by Siker (col. 1, lines 45-46, col. 3, lines 48-51).
Claims 6, 8, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Schentag et al. (US 20130225922 A1), hereinafter referred to as Schentag as applied to claim 1 and claim 11 above, and further in view of Aina-Mumuney et al. (US 20130053670 A1), hereinafter referred to as Aina-Mumuney.
Regarding claim 6, Schentag discloses the system of claim 1, wherein the smartphone application (para. [0057], para. [0061], para. [0063]) is further configured to analyze patient parameters including cervical dilatation (para. [0056], “monitor the dilation of the cervix …”), presence of fFN (para. [0039-0041], “analyte sensor …”, para. [0117], “fetal fibronectin”), fetal heart rate (para. [0085], “heart rate measures from … fetus”) to assess the risk of preterm labor.
However, Schentag does not explicitly disclose the smartphone application is further configured to analyze patient parameters including gestational age, cervical length, and previous risk history to assess the risk of preterm labor.
Aina-Mumuney teaches an analogous system for detecting onset of labor comprising a disposable cervical device and a smartphone application configured to receive data from the cervical device and provide an indication of onset of labor (Abstract, Fig. 1, Fig. 7A, para. [0012-0013], para. [0057]). Aina-Mumuney further teaches analyzing patient parameters including gestational age (para. [0071], para. [0097]), cervical length (para. [0080]), and previous risk history (para. [0057]) to assess the risk of preterm labor (para. [0071]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by Schentag to additionally analyze gestational age, cervical length, and previous risk history to assess the risk of preterm labor, as taught by Aina-Mumuney. Additionally analyzing gestational age, cervical length, and previous risk history would yield the predictable result of a more complete labor onset risk assessment (para. [0071]).
Regarding claim 8, Schentag discloses the system of claim 1, wherein the indication of labor onset or risk thereof is based on a combination of detected presence of fFN (para. [0039-0041], “analyte sensor …”, para. [0117], “fetal fibronectin”) and cervical dilatation (para. [0056], “monitor the dilation of the cervix …”).
However, Schentag does not explicitly disclose the indication of labor onset or risk thereof is based additionally on cervical shortening.
Aina-Mumuney teaches an analogous system for detecting onset of labor comprising a disposable cervical device and a smartphone application configured to receive data from the cervical device and provide an indication of onset of labor (Abstract, Fig. 1, Fig. 7A, para. [0012-0013], para. [0057]). Aina-Mumuney further teaches the indication is based additionally on cervical shortening (para. [0080]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by Schentag to additionally provide the indication based on cervical shortening, as taught by Aina-Mumuney. Additionally providing the indication based on cervical shortening would yield the predictable result of a more complete labor onset risk assessment (para. [0071]).
Regarding claim 16, Schentag discloses the method of claim 11, further comprising analyzing patient parameters including cervical dilatation (para. [0056], “monitor the dilation of the cervix …”), presence of fFN (para. [0039-0041], “analyte sensor …”, para. [0117], “fetal fibronectin”), fetal heart rate (para. [0085], “heart rate measures from … fetus”) to assess the risk of preterm labor with the smartphone application (para. [0057], para. [0061], para. [0063]).
However, Schentag does not explicitly disclose analyzing gestational age, cervical length, and previous risk history to assess the risk of preterm labor with the smartphone application.
Aina-Mumuney teaches an analogous method for detecting onset of labor comprising a disposable cervical device and a smartphone application configured to receive data from the cervical device and provide an indication of onset of labor (Abstract, Fig. 1, Fig. 7A, para. [0012-0013], para. [0057]). Aina-Mumuney further teaches analyzing patient parameters including gestational age (para. [0071], para. [0097]), cervical length (para. [0080]), and previous risk history (para. [0057]) to assess the risk of preterm labor (para. [0071]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Schentag to additionally analyze gestational age, cervical length, and previous risk history to assess the risk of preterm labor, as taught by Aina-Mumuney. Additionally analyzing gestational age, cervical length, and previous risk history would yield the predictable result of a more complete labor onset risk assessment (para. [0071]).
Regarding claim 17, Schentag discloses the method of claim 11, wherein the indication of labor onset or risk thereof is based on a combination of detected presence of fFN (para. [0039-0041], “analyte sensor …”, para. [0117], “fetal fibronectin”), and cervical dilatation (para. [0056], “monitor the dilation of the cervix …”).
However, Schentag does not explicitly disclose the indication of labor onset or risk thereof is additionally based on cervical shortening.
Aina-Mumuney teaches an analogous method for detecting onset of labor comprising a disposable cervical device and a smartphone application configured to receive data from the cervical device and provide an indication of onset of labor (Abstract, Fig. 1, Fig. 7A, para. [0012-0013], para. [0057]). Aina-Mumuney further teaches the indication is based additionally on cervical shortening (para. [0080]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Schentag to additionally provide the indication based on cervical shortening, as taught by Aina-Mumuney. Additionally providing the indication based on cervical shortening would yield the predictable result of a more complete labor onset risk assessment (para. [0071]).
Regarding claim 18, Schentag discloses the method of claim 11.
However, modified Schentag does not explicitly disclose wherein the disposable cervical device is configured for use by a high-risk pregnant mother with a previous history of miscarriages or preterm births or a pregnant mother likely to be in false labor.
Aina-Mumuney teaches an analogous method for detecting onset of labor comprising a disposable cervical device and a smartphone application configured to receive data from the cervical device and provide an indication of onset of labor (Abstract, Fig. 1, Fig. 7A, para. [0012-0013], para. [0057]). Aina-Mumuney further teaches the disposable cervical device is configured for use by a high-risk pregnant mother with a previous history of miscarriages or preterm births or a pregnant mother likely to be in false labor (para. [0071]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Schentag to additionally utilize the device by a high-risk pregnant mother with a previous history of miscarriages or preterm births or a pregnant mother likely to be in false labor, as taught by Aina-Mumuney. This is because Aina-Mumuney teaches monitoring uterine activity with direct application to the cervix provides more accuracy for early preterm labor identification (para. [0071]).
Conclusion
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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