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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign mentioned in the description: System “100”, as stated in Paragraph 0081. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 15 is objected to because of the following informality: “securing a wearable medical device of to a user” in line 2 should read “securing a wearable medical device to a user”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5-11 and 15-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor, at the time the application was filed, had possession of the claimed invention. The specification does not explain at all how the models or the artificial intelligence models operate, or how they are trained before being used in said invention. The algorithms, steps, or procedures taken to operate and train the models and artificial intelligence models must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended to operate and train said models. See MPEP §§ 2163.02 and 2181, subsection IV.
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 15, 16, and 18-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to computer-implemented human thought and mathematical concepts without significantly more. Claim 15 recites “applying one or more artificial intelligence models to the data”. Claim 16 recites “applying one or more models … to determine a trend for a series of data measurements”. Claim 18 recites “the models are applicable to a respective type of data”. Claim 19 recites “updating the one or more models based on previous trends”. This judicial exception is not integrated into a practical application because the claim language describes the use of models or artificial intelligence models to perform mathematical trend calculations and updates that could be done by hand. Furthermore, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the processors and non-transitory computer-readable storage medium are being used simply as tools to perform abstract ideas.
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.
Claims 1, 5-6, 9-12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Khan et al. (U.S. PGPub No. 2024/0215914) in view of Barton-Sweeney (WIPO Pub. No. 2015/143259).
Regarding claim 1, Khan teaches a wearable medical device (Fig. 2A, paragraph
0107, lines 2-3) comprising: an attachment component (Fig. 2A, paragraph 0107, line 11) that at least temporarily secures (Paragraph 0112, lines 2-3) the wearable medical device to skin (Fig. 2A, paragraph 0107, line 12) of a user (Fig. 2A, paragraph 0107, line 12); and one sensor (Fig. 2A, paragraph 0107, lines 23-25) configured to capture data.
Khan does not teach that the one or more sensors are configured to capture data
indicative of one or more fertility characteristics of the user. Barton-Sweeney, however, teaches a fertility monitoring device (Fig. 4, paragraph 0042, lines 1-2) that uses one or more sensors (Paragraph 0045, line 1) to capture data (Paragraph 0049, line 1) indicative of one or more fertility characteristics of the user (Paragraph 0037, lines 3-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khan to incorporate the teachings of Barton-Sweeney to include one or more sensors that are configured to capture data indicative of one or more fertility characteristics of the user. Doing so would ensure that a variety of metrics correlating to fertility level and status can be tracked with a wearable medical device, as recognized by Barton-Sweeney.
Regarding claim 5, Khan teaches the wearable medical device (Fig. 2A,
paragraph 0107, lines 2-3) of claim 1. Khan does not teach that the medical device further comprises one or more processors, wherein the one or more processors are configured to: log the data in a database as part of a series of respective data measurements; apply one or more models to the series of respective data measurements to determine a trend for the series of respective data measurements; and based on the trend for the series of respective data measurements, determine the one or more fertility characteristics of the user.
Barton-Sweeney, however, teaches a fertility monitoring device (Fig. 4, paragraph
0042, lines 1-2) that comprises one or more processors (Paragraph 0076, lines 3-4), wherein the one or more processors are configured to: log the data in a database (Paragraph 0103, line 6) as part of a series (Paragraph 0101, lines 5-6) of respective data measurements (Paragraph 0103, lines 13-14); apply one or more models (Paragraph 0103, line 5) to the series of respective data measurements to determine a trend (Paragraph 0104, lines 3-4) for the series of respective data measurements; and based on the trend for the series of respective data measurements (Paragraph 0104, lines 1-2), determine the one or more fertility characteristics of the user (Paragraph 0104, line 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khan to incorporate the teachings of Barton-Sweeney to include one or more processors that log the data in a database as part of a series of respective data measurements; applying one or more models to determine a trend for the measurements; and based on the trend for the measurements, determining the one or more fertility characteristics of the user. Doing so would ensure that the wearable medical device includes modules to store data and means to analyze trends of said data to help determine fertility characteristics, as recognized by Barton-Sweeney.
Regarding claim 6, Khan teaches the wearable medical device (Fig. 2A,
paragraph 0107, lines 2-3) of claim 1. Khan does not teach that the medical device comprises one or more processors that are further configured to: output a notification to one or more of an alert device in the wearable medical device or a secondary computing device, the notification indicating the one or more fertility characteristics of the user.
Barton-Sweeney, however, teaches a fertility monitoring device (Fig. 4, paragraph
0042, lines 1-2) that comprises one or more processors (Paragraph 0076, lines 3-4) that are further configured to: output a notification (Paragraph 0042, line 8) to one or more of an alert device (Paragraph 0042, line 4) in the fertility monitoring device or a secondary computing device (Paragraph 0053, lines 2 and 5-12), the notification indicating the one or more fertility characteristics of the user (Paragraph 0042, lines 9-10).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Khan to incorporate the teachings of Barton-Sweeney to include that the one or more processors are configured to output a notification to the wearable medical device and a secondary computing device to indicate the one or more fertility characteristics. Doing so would ensure that the user has a means for understanding what their fertility status is, as recognized by Barton-Sweeney.
Regarding claim 9, Khan teaches the wearable medical device (Fig. 2A,
paragraph 0107, lines 2-3) of claim 5. Khan does not teach that the medical device comprises one or more processors that are configured to: transmit, via a communication unit, the data to a secondary computing device for analysis. Barton-Sweeney, however, teaches a fertility monitoring device (Fig. 4, paragraph 0042, lines 1-2) that comprises one or more processors (Paragraph 0076, lines 3-4) that are configured to: transmit, via a communication unit (Paragraph 0046, line 10), the data to a secondary computing device for analysis (Paragraph 0047, lines 1-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khan to incorporate the teachings of Barton-Sweeney to include that the one or more processors can transmit, via a communication unit, data to a secondary computing device for analysis. Doing so would ensure that the wearable medical device has a means for transmitting the user data to a secondary computing device, as recognized by Barton-Sweeney.
Regarding claim 10, Khan teaches the wearable medical device (Fig. 2A,
paragraph 0107, lines 2-3) of claim 5. Khan does not teach that the medical device comprises one or more processors that are configured to control the one or more sensors to capture the data indicative of the one or more fertility characteristics.
Barton-Sweeney, however, teaches a fertility monitoring device (Fig. 4, paragraph 0042, lines 1-2) that comprises one or more processors (Paragraph 0076, lines 3-4) that are configured to control (Paragraph 0046, lines 1-4 and 7-8) the one or more sensors (Paragraph 0045, line 1) to capture the data (Paragraph 0049, line 1) indicative of the one or more fertility characteristics (Paragraph 0037, lines 3-6).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Khan to incorporate the teachings of Barton-Sweeney to include that the one or more processors control the one or more sensors to capture the data indicative of the one or more fertility characteristics. Doing so would ensure that the wearable medical device has a means to control the one or more sensors, as recognized by Barton-Sweeney.
Regarding claim 11, Khan teaches the wearable medical device (Fig. 2A,
paragraph 0107, lines 2-3) of claim 10. Khan does not teach that the processors are configured to control the one or more sensors to the data indicative of the one or more fertility characteristics in one or more of: at a particular set of one or more times each day, in response to receiving an indication of user input at the wearable medical device, and in response to receiving an indication of user input at a secondary computing device.
Barton-Sweeney, however, teaches a fertility monitoring device (Fig. 4, paragraph
0042, lines 1-2) that comprises one or more processors (Paragraph 0076, lines 3-4) that are configured to control (Paragraph 0046, lines 1-4 and 7-8) the one or more sensors (Paragraph 0045, line 1) to the data (Paragraph 0049, line 1) indicative of the one or more fertility characteristics (Paragraph 0037, lines 3-6) in one or more of: at a particular set of one or more times each day (Paragraph 0096, lines 2-3 and paragraph 0108, lines 6-8), in response to receiving an indication of user input at the fertility monitoring device (Paragraph 0096, lines 7-8), and in response to receiving an indication of user input at a secondary computing device (Paragraph 0054, lines 1-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khan to incorporate the teachings Barton-Sweeney to include that the processors control the one or more sensors at a particular set of one or more times each day in response to receiving a user input at the wearable medical device and at the secondary computing device. Doing so would ensure that the user can initiate data collection at a specific time or times of day from their wearable medical device and secondary computing device, as recognized by Barton-Sweeney.
Regarding claim 12, Khan teaches the wearable medical device (Fig. 2A,
paragraph 0107, lines 2-3) of claim 1. Khan does not teach that the medical device captures data indicative of one or more fertility characteristics, wherein the one or more fertility characteristics comprise one or more of: a fertile window of the user; an ovulation for the user; a pregnancy of the user; and a non-pregnancy of the user.
Barton-Sweeney, however, teaches a fertility monitoring device (Fig. 4, paragraph 0042, lines 1-2) that captures data (Paragraph 0049, line 1) indicative of one or more fertility characteristics of the user (Paragraph 0037, lines 3-6), wherein said fertility characteristics include a fertile window of the user (Paragraph 0037, lines 4-6), an ovulation for the user (Paragraph 0037, line 6), a pregnancy of the user (Paragraph 0138, line 8), and a non-pregnancy of the user (Paragraph 0037, line 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khan to incorporate the teachings of Barton-Sweeney to include that the wearable medical device captures data indicative of one or more fertility characteristics, wherein the one or more fertility characteristics comprise one or more of: a fertile window of the user; an ovulation for the user; a pregnancy of the user; and a non-pregnancy of the user. Doing so would ensure that all fertility levels and fertility status can be determined with the wearable medical device, as recognized by Barton-Sweeney.
Regarding claim 14, Khan teaches the wearable medical device (Fig. 2A,
paragraph 0107, lines 2-3) of claim 1, wherein the attachment component (Fig. 2A, paragraph 0107, line 11) comprises an adhesive layer (Paragraph 0107, lines 10-12) that at least temporarily adheres (Paragraph 0112, lines 2-3) the wearable medical device to the skin of the user (Fig. 2A, paragraph 0107, line 12).
Khan does not teach that the attachment component can comprise a strap to wrap around a body of the user. Barton-Sweeney, however, teaches a fertility monitoring device (Fig. 4, paragraph 0042, lines 1-2), where one embodiment has a strap (Fig. 17A-17R) to wrap around a body of the user (Fig. 17A-17R, paragraph 0134, lines 9-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khan to incorporate the teachings of Barton-Sweeney to include that the attachment component can comprise a strap to wrap around a body of the user. Doing so would provide an alternative or additional means to keep the wearable medical device securely attached to the skin of the user, as recognized by Barton-Sweeney.
Regarding claim 15, Khan teaches a method (Paragraph 0013, lines 1-3)
comprising: securing (Paragraph 0014, lines 23-25) a wearable medical device (Fig. 2A, paragraph 0107, lines 2-3) of to a user (Fig. 2A, paragraph 0107, line 12), the wearable medical device comprising: an attachment component (Fig. 2A, paragraph 0107, line 11) that at least temporarily secures (Paragraph 0112, lines 2-3) the wearable medical device to skin (Fig. 2A, paragraph 0107, line 12) of the user; and one or more sensors (Fig. 2A, paragraph 0107, lines 23-25) configured to capture data.
Khan does not teach that the one or more sensors are configured to capture data
indicative of one or more fertility characteristics. Khan also does not teach a method that includes: receiving, by one or more processors, the data indicative of the one or more fertility characteristics of the user from the wearable medical device; applying, by the one or more processors, one or more artificial intelligence models to the data; and determining, by the one or more processors, one or more fertility characteristics of the user.
Barton-Sweeney, however, teaches a fertility monitoring device (Fig. 4, paragraph 0042, lines 1-2) that uses one or more sensors (Paragraph 0045, line 1) to capture data (Paragraph 0049, line 1) indicative of one or more fertility characteristics of the user (Paragraph 0037, lines 3-6). Barton-Sweeney also teaches that one or more processors (Paragraph 0076, lines 3-4) receive the data (Paragraph 0046, lines 2-3) indicative of the one or more fertility characteristics of the user from the monitoring device, apply one or more artificial intelligence models to the data (Paragraph 0103, line 5), and determine one or more fertility characteristics of the user (Paragraph 0104, line 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khan to incorporate the teachings of Barton-Sweeney to include that the one or more sensors capture data indicative of one or more fertility characteristics, and to include that the one or more processors receive the data, apply one or more artificial intelligence models to the data, and determine one or more fertility characteristics of the user. Doing so would ensure that a variety of metrics correlating to fertility level and status can be tracked with a wearable medical device, and that said device has a means for receiving data and applying models to determine fertility characteristics, as recognized by Barton-Sweeney.
Claims 2-4 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Khan et al. (U.S. PGPub No. 2024/0215914) in view of Barton-Sweeney (WIPO Pub. No. 2015/143259) and Bunn (WIPO Pub. No. 2024/192175).
Regarding claim 2, Khan teaches the wearable medical device (Fig. 2A, paragraph 0107, lines 2-3) of claim 1, wherein the one or more sensors (Fig. 2A, paragraph 0107, lines 23-25) comprise one or more of: one hormone-detecting (Paragraph 0105, lines 1 and 60-63) sensor (Fig. 2A, paragraph 0107, lines 23-25) configured to capture one or more hormone levels (Paragraph 0105, lines 1 and 60-63), either incorporated into or in fluid communication with one or more microneedles (Fig. 3, paragraph 0113, lines 13-15) that extend out of the wearable medical device (Fig. 2-3), wherein, when the attachment component (Fig. 2A, paragraph 0107, line 11) is secured (Paragraph 0112, lines 2-3) to the skin (Fig. 2A, paragraph 0107, line 12) of the user (Fig. 2A, paragraph 0107, line 12), the one or more microneedles are inserted through the skin of the user (Paragraph 0124, lines 5-7) such that the one or more microneedles contact interstitial fluid beneath the skin of the user (Paragraph 0104, lines 1-8) from which the one or more hormone-detecting sensors measure the one or more hormone levels.
Khan does not teach that the wearable medical device includes one or more hormone-detecting sensors, one or more temperature sensors configured to capture a basal body temperature (BBT) of the user, or one or more ultrasound devices configured to capture one or more ultrasound images of the user. Barton-Sweeney, however, teaches a fertility monitoring device (Fig. 4, paragraph 0042, lines 1-2) that uses one or more sensors (Paragraph 0045, line 1). Barton-Sweeney also teaches that the one or more sensors can be one or more temperature sensors (Paragraph 0045, lines 2-3) configured to capture a basal body temperature of the user (Paragraph 0045, lines 3-5).
Bunn, however, teaches an artificial intelligence system and method that can provide continuous (Paragraph 0019, line 8) pregnancy and gynecological monitoring (Paragraph 0019, line 5) using wearable devices, such as ultrasound patches (Paragraph 0019, lines 8-9), that capture one or more ultrasound images of the user (Paragraph 0013, line 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khan to incorporate the teachings of Barton-Sweeney and Bunn to include that the wearable medical device includes one or more sensors, one or more temperature sensors configured to capture basal body temperature (BBT), and one or more ultrasound devices configured to capture one or more ultrasound images. Doing so would ensure that hormone levels, temperature levels, and medical imaging can all be used to accurately determine fertility characteristics of the user, as recognized by Barton-Sweeney and Bunn.
Regarding claim 3, Khan in view of Barton-Sweeney and Bunn discloses the
claimed invention of claim 2. Khan further discloses the wearable medical device (Fig. 2A, paragraph 0107, lines 2-3) of claim 2 that can measure hormone levels (Paragraph 0105, lines 1 and 60-63). Khan does not teach that the one or more hormone levels comprise one or more of: a luteinizing hormone level; a follicle stimulating hormone; estrogen; progesterone; and a human chorionic gonadotropin level.
Barton-Sweeney, however, teaches a fertility monitoring device (Fig. 4, paragraph 0042, lines 1-2) that uses one or more sensors (Paragraph 0045, line 1) to measure one or more hormone levels (Paragraph 0157, line 6) such as a luteinizing hormone levels (Paragraph 0156, line 3), follicle stimulating hormone (Paragraph 0156, lines 4-5), estrogen (Paragraph 0156, line 5), progesterone (Paragraph 0156, line 5), and human chorionic gonadotropin levels (Paragraph 0156, line 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khan to incorporate the teachings of Barton-Sweeney to include that the wearable medical device can measure one or more hormone levels such as luteinizing hormone levels, follicle stimulating hormone, estrogen, progesterone, and human chorionic gonadotropin levels. Doing so would ensure that the hormones that are indicative of one or more fertility characteristics of the user are able to be measured by said device, as recognized by Barton-Sweeney.
Regarding claim 4, Khan in view of Barton-Sweeney and Bunn discloses the
claimed invention of claim 2. Khan does not teach that the one or more ultrasound images include representations of one or more of: a dominant follicle on an ovary; a corpus luteum cyst; an endometrium; and free fluid adjacent to the ovary or in a posterior cul-de-sac.
Bunn, however, teaches an artificial intelligence system and method that can provide continuous (Paragraph 0019, line 8) pregnancy and gynecological monitoring (Paragraph 0019, line 5) using wearable devices, such as ultrasound patches (Paragraph 0019, lines 8-9), that capture one or more ultrasound images of the user (Paragraph 0013, line 2). Furthermore, Bunn teaches that the one or more ultrasound images can include representations of one or more of: a dominant follicle on an ovary (Paragraph 0023, lines 10-11); a corpus luteum cyst (Page 150, line 3 and page 151, line 7); and an endometrium (Page 151, line 8).
Although Bunn does not explicitly teach that the ultrasound images can include representations of free fluid adjacent to the ovary or in a posterior cul-de-sac, it would be well understood by a person of ordinary skill in the art that ultrasound images that are taken of the female reproductive system for gynecological monitoring would include visibility of said features, as this is well known human anatomy.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khan to incorporate the teachings of Bunn to include that the ultrasound images can include representations of one or more of a dominant follicle on an ovary, a corpus luteum cyst, an endometrium, and free fluid adjacent to the ovary or in a posterior cul-de-sac. Doing so would ensure that critical components of the female reproductive system can be imaged and analyzed to improve accurate determination of fertility characteristics of the user, as recognized by Bunn.
Regarding claim 7, Khan teaches a wearable medical device (Fig. 2A, paragraph
0107, lines 2-3) that includes a hormone-detecting (Paragraph 0105, lines 1 and 60-63) sensor (Fig. 2A, paragraph 0107, lines 23-25) configured to capture one or more hormone levels (Paragraph 0105, lines 1 and 60-63) from interstitial fluid beneath the skin of the user (Paragraph 0104, lines 1-8). Khan does not teach that the wearable medical device of claim 5 applies one or more models to a respective type of the data logged in the database, wherein the type of the data comprises one or more of: a basal body temperature (BBT) of the user and an ultrasound image of the user.
Barton-Sweeney, however, teaches a fertility monitoring device (Fig. 4, paragraph 0042, lines 1-2) that uses one or more temperature sensors (Paragraph 0045, lines 2-3) to capture a basal body temperature (BBT) of the user (Paragraph 0045, lines 3-5). Barton-Sweeney teaches applying models to the basal body temperature data (Paragraph 0099, lines 11-13). Barton-Sweeney also teaches applying hormone level models (Paragraph 0159, lines 3-4) to determine hormone levels of the user (Paragraph 0159, line 7).
Bunn, however, teaches an artificial intelligence system and method that can provide continuous (Paragraph 0019, line 8) pregnancy and gynecological monitoring (Paragraph 0019, line 5) using wearable devices, such as ultrasound patches (Paragraph 0019, lines 8-9), that capture one or more ultrasound images of the user (Paragraph 0013, line 2). Furthermore, Bunn teaches that models can be applied to the ultrasound images to provide further analysis and quantitative predictions (Paragraph 0013, lines 2-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khan to incorporate the teachings of Bunn to include that the one or more models are applicable to a respective type of the data logged in the database, wherein the type of the data comprises hormone levels, basal body temperature (BBT), and ultrasound images. Doing so would ensure that specific models are used to determine trends for each type of data, as recognized by Bunn.
Regarding claim 8, Khan in view of Barton-Sweeney and Bunn discloses the
claimed invention of claim 7. Khan does not teach that the medical device comprises one or more processors that are further configured to update any of the one or more models based on previous trends for the respective type of the data.
Barton-Sweeney, however, teaches a fertility monitoring device (Fig. 4, paragraph
0042, lines 1-2) that comprises one or more processors (Paragraph 0076, lines 3-4) that are further configured to update (Paragraph 0102, lines 1-4) any of the one or more models (Paragraph 0103, line 5) based on previous trends (Paragraph 0104, lines 3-4) for the respective type of the data (Paragraph 0103, lines 7-10).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Khan to incorporate the teachings of Barton-Sweeney to include that the one or more processors can update the one or more models based on previous trends for the respective type of data. Doing so would ensure that the models are continuously updated with patient data in order to more accurately determine user fertility characteristics, as recognized by Barton-Sweeney.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Khan et al. (U.S. PGPub No. 2024/0215914) in view of Robinson et al. (WIPO Pub. No. 2024/238888).
Regarding claim 13, Khan teaches the wearable medical device (Fig. 2A, paragraph 0107, lines 2-3) of claim 1. Khan does not teach that the wearable medical device has a color chosen from one of a plurality of different skin tone shades. Robinson, however, teaches a wearable medical device (Fig. 1, Paragraph 0077, line 2) that has a color chosen from one of a plurality of different skin tone shades (Paragraph 00128, lines 1-3). Although Robinson does not explicitly state that the color is chosen from one of a plurality of different skin tone shades, Robinson does disclose that “the device can be colored customized so as to match a skin tone of the user”. It would be well known to a person of ordinary skill in the art that matching the color of the device to a custom skin tone of the user would encompass one of a plurality of different skin tone shades.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Khan to incorporate the teachings of Robinson to include that the wearable medical device color can be chosen from a plurality of different skin tone shades. Doing so would ensure that the wearable medical device blends into the skin of users with all different skin tones, so the device is less noticeable, as recognized by Robinson.
Claims 16-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Barton-Sweeney (WIPO Pub. No. 2015/143259) in view of Khan et al. (U.S. PGPub No. 2024/0215914).
Regarding claim 16, Barton-Sweeney teaches a non-transitory computer-readable storage medium (Paragraph 0079, lines 1-10) comprising instructions (Paragraph 0075, line 2) that, when executed by (Paragraph 0046, line 8) one or more processors (Paragraph 0076, lines 3-4), cause the one or more processors to: control (Paragraph 0046, line 10) one or more sensors (Paragraph 0045, line 1) to capture data (Paragraph 0049, line 1) indicative of one or more fertility characteristics of the user (Paragraph 0037, lines 3-6); log the data in a database (Paragraph 0103, line 6) as part of a series (Paragraph 0101, lines 5-6) of respective data measurements (Paragraph 0103, lines 13-14); apply one or more models (Paragraph 0103, line 5) to the series of respective data measurements to determine a trend (Paragraph 0104, lines 3-4) for the series of respective data measurements; and based on the trend for the series of respective data measurements (Paragraph 0104, lines 1-2), determine the one or more fertility characteristics of the user (Paragraph 0104, line 2).
Barton-Sweeney does not teach that the one or more sensors are on a wearable medical device secured to a user. Khan, however, teaches a wearable medical device (Fig. 2A, paragraph 0107, lines 2-3) that includes one sensor (Fig. 2A, paragraph 0107, lines 23-25) configured to capture data. Khan also teaches that the wearable medical device can be secured (Paragraph 0112, lines 2-3) to the user (Fig. 2A, paragraph 0107, line 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Barton-Sweeney to incorporate the teachings of Khan to include a wearable medical device that includes a sensor configured to capture data and can be secured to the user. Doing so would provide a minimally invasive means for capturing data indicative of one or more fertility characteristics of a user, as recognized by Khan.
Regarding claim 17, Barton-Sweeney teaches the non-transitory computer-readable storage medium (Paragraph 0079, lines 1-10) of claim 16, wherein the instructions (Paragraph 0075, line 2), when executed (Paragraph 0046, line 8), further cause the one or more processors to (Paragraph 0076, lines 3-4): output a notification (Paragraph 0042, line 8) to one or more of an alert device (Paragraph 0042, line 4) in a fertility monitoring device (Fig. 4, paragraph 0042, lines 1-2) or a secondary computing device (Paragraph 0053, lines 2 and 5-12), the notification indicating the one or more fertility characteristics of the user (Paragraph 0042, lines 9-10).
Barton-Sweeney does not teach that the one or more sensors are on a wearable medical device secured to a user. Khan, however, teaches a wearable medical device (Fig. 2A, paragraph 0107, lines 2-3) that includes one sensor (Fig. 2A, paragraph 0107, lines 23-25) configured to capture data. Khan also teaches that the wearable medical device can be secured (Paragraph 0112, lines 2-3) to the user (Fig. 2A, paragraph 0107, line 12).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Barton-Sweeney to incorporate the teachings of Khan to include that the one or more processors are configured to output a notification to the wearable medical device to indicate the one or more fertility characteristics. Doing so would ensure that the user has a means for understanding what their fertility status is, as recognized by Barton-Sweeney.
Regarding claim 20, Barton-Sweeney in view of Khan discloses the claimed invention of claim 16. Barton-Sweeney further discloses the non-transitory computer-readable storage medium (Paragraph 0079, lines 1-10) of claim 16, wherein the instructions (Paragraph 0075, line 2), when executed (Paragraph 0046, line 8), cause the one or more processors (Paragraph 0076, lines 3-4) to control (Paragraph 0046, lines 1-4 and 7-8) the one or more sensors (Paragraph 0045, line 1) to the data (Paragraph 0049, line 1) indicative of the one or more fertility characteristics (Paragraph 0037, lines 3-6) in one or more of: at a particular set of one or more times each day (Paragraph 0096, lines 2-3 and paragraph 0108, lines 6-8), in response to receiving an indication of user input at the fertility monitoring device (Paragraph 0096, lines 7-8), and in response to receiving an indication of user input at a secondary computing device (Paragraph 0054, lines 1-5).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Barton-Sweeney (WIPO Pub. No. 2015/143259) in view of Khan et al. (U.S. PGPub No. 2024/0215914) and Bunn (WIPO Pub. No. 2024/192175).
Regarding claim 18, Barton-Sweeney teaches the non-transitory computer-readable storage medium (Paragraph 0079, lines 1-10) of claim 16, wherein the each of the one or more models (Paragraph 0103, line 5) are applicable to a respective type (Paragraph 0103, lines 13-14) of the data logged in the database (Paragraph 0103, line 6), wherein the type of the data comprises one or more of: one or more hormone levels (Paragraph 0159, lines 3-4 and 7) and a basal body temperature (BBT) of the user (Paragraph 0045, lines 3-5 and Paragraph 0099, lines 11-13).
Barton-Sweeney does not teach that the types of data include hormone levels from
interstitial fluid beneath the skin of the user and an ultrasound image of the user. Khan, however, teaches a wearable medical device (Fig. 2A, paragraph 0107, lines 2-3) that includes a hormone-detecting (Paragraph 0105, lines 1 and 60-63) sensor (Fig. 2A, paragraph 0107, lines 23-25) configured to capture one or more hormone levels (Paragraph 0105, lines 1 and 60-63) from interstitial fluid beneath the skin of the user (Paragraph 0104, lines 1-8).
Bunn, however, teaches an artificial intelligence system and method that can provide continuous (Paragraph 0019, line 8) pregnancy and gynecological monitoring (Paragraph 0019, line 5) using wearable devices, such as ultrasound patches (Paragraph 0019, lines 8-9), that capture one or more ultrasound images of the user (Paragraph 0013, line 2). Furthermore, Bunn teaches that models can be applied to the ultrasound images to provide further analysis and quantitative predictions (Paragraph 0013, lines 2-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Barton-Sweeney to incorporate the teachings of Khan and Bunn to include that the one or more models are applicable to a respective type of the data logged in the database, wherein the type of the data comprises hormone levels and ultrasound images. Doing so would ensure that specific models are used to determine trends for each type of data, as recognized by Bunn.
Regarding claim 19, Barton-Sweeney in view of Khan and Bunn discloses the claimed invention of claim 18. Barton-Sweeney further discloses the non-transitory computer-readable storage medium (Paragraph 0079, lines 1-10) of claim 18, wherein the instructions (Paragraph 0075, line 2), when executed (Paragraph 0046, line 8), further cause the one or more processors to (Paragraph 0076, lines 3-4): update (Paragraph 0102, lines 1-4) any of the one or more models (Paragraph 0103, line 5) based on previous trends (Paragraph 0104, lines 3-4) for the respective type of the data (Paragraph 0103, lines 7-10).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: WIPO Pub. No. 2024/218610, WIPO Pub. No. 2021/037724, U.S. PGPub No. 2022/0409186, U.S. PGPub No. 2022/0361855, WIPO Pub. No. 2011/139405, and U.S. Patent No. 9,155,523.
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/H.A.H./Patent Examiner , Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796