Examiner requests an interview with Applicant in order to advance the instant application to allowance. Please call Examiner at the number provided below.
DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-24 are pending.
Claim Objections
Claim 17 and all dependent claims therefrom are objected to because of the following informalities: closing parenthesis “[sleep])” has no corresponding opening parenthesis. Appropriate correction is required.
Claim Rejections - 35 USC § 112, Second Paragraph
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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 1-24 and all dependent claims therefrom are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 recites the limitation “the occurrence” and “the burden.”
Claims 6, 22, 24 recite the limitation “the user.”
Claim 6 recites the limitation “the set of words.”
Claim 8 recites the limitation “the device display.”
Claim 11 recites “the integration of multiple user data.”
Claims 17, 18, and 19 recite “the user’s data” and “the team's data.”
Claim 19 recites “the user’s physiological data.”
Claim 20 and 23 recite the limitation “the individual data,” “the integrated data,” “the observed relationship,” and “the correlated/trending integrated data.”
Claims 15 recites the limitation “the model,” “the output,” and “the next set up data.”
There are insufficient antecedent bases for the limitations in the claims.
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 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: a device that is attached to the baby and a device that is attached to the mother. These two devices and their attachment must be explicitly recited because they are essential elements.
Claims 15-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01.
The determination of whether there is a rejection under 112(a) for inadequate written description and/or lack of enablement is made on a case-by-case basis and examiners should consult MPEP 2163(I), 2163.05, and 2164.08(c). See also MPEP 2172.01, Paragraph 2 (emphasis added) (“… a claim which omits matter disclosed to be essential to the invention as described in the specification or in other statements of record may be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as not enabling; under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as lacking an adequate written description; under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, as indefinite; or under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, as failing to claim the subject matter that the inventor or a joint inventor (or, for applications subject to pre-AIA 35 U.S.C. 112, the applicant) regards as the invention. Such essential matter may include missing elements, steps or necessary structural cooperative relationships of elements described by the applicant(s) as necessary to practice the invention.”); MPEP 2172.01, Paragraph 3 (“If a claim omits matter that appears to be necessary to adequately describe the invention, or to make and use the invention, follow the guidance set forth in MPEP § 2163 et seq. (especially § 2163, subsection I, and § 2163.05) and MPEP § 2164 et seq. (especially § 2164.08(c)), respectively, to determine whether a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, based on an inadequate written description and/or lack of enablement should be made.”).
To properly reject a claim under 35 U.S.C. 112(a) or 112(b) for unclaimed essential matter (e.g., Form Paragraphs 7.31.01, 7.33.01, 7.34.12-.14): (1) The specification or other statements of record must disclose that the subject matter omitted as essential or critical by a literal, explicit statement, not just illustrative or preferred; and (2) the rejection must explain the basis for concluding that the inventor regards the omitted matter to be essential to the invention (MPEP 2172.01, Paragraph 5).
For the instant claimed invention, the omitted steps are: attaching a device to the baby and attaching a device to the mother. Attaching these two devices must be explicitly recited because they are essential steps. The instant Specification teaches the following (with emphases added):
[00011] “Therefore, what is missing in the baby tracking market place is the combination of 10 wearable electronic devices for both the mother and the mother and baby …”
[00046] “The wearable device of the present invention teaches simple/minimal steps for
10 setup and operation where multiple postnatal actions such as: nursing, feeding, sleeping, diaper change, bath, medicine administration, etc. can be tracked. Multiple postpartum actions such as eating, fluid intake, exercise, sleep, etc. can also be tracked.”
Claim 1. A wearable device for tracking, reminding/alerting, correlating, predicting, suggesting, documenting, integrating, and transmitting postnatal and postpartum care and development events, comprising a touch screen providing touch control and input, a microphone providing voice recognition/control and input; machine learning and predictive analytics, to monitor the occurrence and duration of postnatal and postpartum care and development events; and an application software to track, remind/ alert, correlate, predict, suggest, document, integrate and transmit past, present and future events to alleviate the burden that users experience with management by manual or less comprehensive methods.
Note that the claim is directed to the specific application of baby/mother tracking (even though the specification may be broader). And for the specific application of baby/mother tracking, tracking the baby is essential. The instant Specification says as much by saying that what is “missing” with other such trackers is the baby tracker. The logical inverse of “missing” (in other products) is “essential” (to this invention). Note further that the MPEP does not say that the literal explicit statement needs to be a positive formulation of criticality, just a literal explicit statement (whether in a positive or negative formulation). In the present invention, we have a negative formulation of the literal explicit statement.
Moreover, Applicant seems to rely on a narrow construal of the term “postnatal” and “postpartum,” with the former as referring to baby-related actions and events and the latter as referring to mother-related actions and events to be monitored and tracked.
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 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stone et al. (US 20190148025 A1, 2019-05-16) (hereinafter “Stone”).
Regarding claim 1, Stone teaches a wearable device for tracking, reminding/alerting, correlating, predicting, suggesting, documenting, integrating, and transmitting postnatal and postpartum care and development events (e.g., [0116]), comprising a touch screen providing touch control and input, a microphone providing voice recognition/control and input (e.g., [0047] and Fig. 2); machine learning and predictive analytics, to monitor the occurrence and duration of postnatal and postpartum care and development events; and an application software to track, remind/ alert, correlate, predict, suggest, document, integrate and transmit past, present and future events to alleviate the burden that users experience with management by manual or less comprehensive methods (e.g., [0053], [0117]-[0122)]) (as recited in claim 1); wherein the wearable device is a smartwatch (e.g., [0035]) (as recited in claim 2); wherein the wearable device is a fitness tracker (e.g., [0035]) (as recited in claim 3); wherein the touch screen is made from passive or active-matrix organic light-emitting diodes (e.g., [0049]) (Official Notice is given that such passive or active-matrix organic light-emitting diodes are widely used for display screens) (as recited in claim 4); wherein the wearable device is controlled by voice recognition, which initially sets up wake word and/or action words by speaking several words/ phrases that will be used (e.g., [0091]) (as recited in claim 5); wherein the device uses a phonetic or universal allowing preset commands approach and will calibrate voice recognition by action to improve accuracy; the user to selects from a list and/or designate alternate words, a pre-set words or a specific set of words/ phrases for each action can be designated.; and the set of words can vary from user to user (e.g., [0091]) (as recited in claim 6);
7. The wearable device of claim 5, wherein machine learning/predictive analytics provides activity recognition and serves to correlate baby and mom/dad/ data to better predict events using statistical analysis/trending techniques (e.g., [0053]) (as recited in claim 7); wherein a series of vibration and color light/LED notifications, which may be on screen or external to the device display (e.g., [0041, [0048]-[0049]]) (as recited in claim 8); further comprising a backlit screen, a camera, flashlight with a nightlight setting, a keyboard, a basic account, a clock, a timer and alarm, a counter/movement tracker, a calendar, data storage on a memory card, local memory, or wirelessly to cloud storage, email, individual or group messaging/ Community chat, and WIFI (e.g., [0033], [0041], [0045], [0053]) (as recited in claim 9).
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 10-24 are rejected under 35 U.S.C. 103 as being unpatentable over Stone in view of Radovcic (US 20200075152 A1, 2020-03-05).
Regarding claims 10-24, Stone teaches a wearable tracking device, as discussed above. However, Stone does not expressly teach use of the invention for a baby. Radovcic teaches tracking, monitoring a baby. See, e.g., [0015]., [0052] [0059]-[0060], [0116], [0119], [0138], [0148]-[0151], [0162]-[0164], [0185]. Note that Stone teaches machine learning. See, e.g., [0022], [0053].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Radovcic taught by with the invention taught by Stone such that further comprising a baby cam feed capability, a point of care adapter-ready to accept devices for providing lateral flow, colorimetric, electrochemical, fluorometric, otoscopic, microscopic, a timer/alarm that can set a schedule, be adjusted if an event is missed or shifted, or include an entire series or specific event; a counter/tracker providing automatic record of entries; a calendar for providing specific reminders such as baby milestone photos, baby appointments, and mom appointments (e.g., [0015]., [0052] [0059]-[0060], [0116], [0119], [0138], [0148]-[0151], [0162]-[0164], [0185]) (as recited in claim 10); further comprising with respect to files and document tracking, entering and storing documents/notes such as one or more health insurance cards, lists, such as baby care shopping lists, a filing folder system for organization, the integration of multiple user data, transmission and export of data to maintain and share records with health providers or other third parties (e.g., [0015]., [0052] [0059]-[0060], [0116], [0119], [0138], [0148]-[0151], [0162]-[0164], [0185]) (as recited in claim 11); further comprising Baby activity tracking; Baby health tracking; Baby milestone tracking; User activity tracking; and User health tracking (e.g., [0015]., [0052] [0059]-[0060], [0116], [0119], [0138], [0148]-[0151], [0162]-[0164], [0185]) (as recited in claim 12); wherein with respect to functionality, the wearable device will track, remind, predict, integrate, correlate, predict, suggest, document and transmit events during postnatal and postpartum care. (e.g., [0015]., [0052] [0059]-[0060], [0116], [0119], [0138], [0148]-[0151], [0162]-[0164], [0185]) (as recited in claim 13); wherein multiple postnatal actions such as: nursing, feeding, sleeping, diaper change, bath, milestones, symptoms, health events, medicine administration, etc. are tracked; and multiple postpartum actions such as eating, fluid intake, pumping, exercise, sleep, symptoms, and health events are tracked (e.g., [0015]., [0052] [0059]-[0060], [0116], [0119], [0138], [0148]-[0151], [0162]-[0164], [0185]) (as recited in claim 14); amethod for tracking, reminding/alerting, correlating, predicting, suggesting, documenting, integrating, and transmitting postnatal and postpartum care and development events in a wearable device, comprising a circular process whereby data collected is run through a data cleaning process and sent to a data preparation module; prepared data is then sent through an algorithm selection module and then to a training module; an evaluation module then takes the data from the training module and generates a prediction as the output, which is then used to update the model; and the process then repeats for the next set up data collected (e.g., [0015]., [0052] [0059]-[0060], [0116], [0119], [0138], [0148]-[0151], [0162]-[0164], [0185] of Radovcic; e.g., [0022], [0053] of Stone) (as recited in claim 15); further comprising wherein combinations of actions are also be tracked; and tracking is done by independent timers for each activity (e.g., [0015], [0052] [0059]-[0060], [0116], [0119], [0138], [0148]-[0151], [0162]-[0164], [0185] of Radovcic; e.g., [0022], [0053] of Stone) (as recited in claim 16); further comprising wherein athletes who play a team sport can track their physiological heart rate, blood pressure, blood oxygen, sleep), behavioral calorie intake, fluid intake, and physical steps, speed, events to correlate the user’s data with another user’s or the team’s data (e.g., [0015]., [0052] [0059]-[0060], [0116], [0119], [0138], [0148]-[0151], [0162]-[0164], [0185] of Radovcic; e.g., [0022], [0053] of Stone) (as recited in claim 17); further comprising wherein workers monitor behavioral shift time, fluid intake, meals, environmental exposure risks, and physiological sleep, symptoms, temperature, heart rate, blood pressure, blood oxygen events to correlate the user’s data with another user’s or the team’s data (e.g., [0015]., [0052] [0059]-[0060], [0116], [0119], [0138], [0148]-[0151], [0162]-[0164], [0185] of Radovcic; e.g., [0022], [0053] of Stone) (as recited in claim 18);, further comprising wherein emergency, laboratory, and industrial workers monitor environmental/chemical/ biological activities, exposure, and physiological symptoms, temperature, heart rate, blood pressure, blood oxygen events to correlate the user’s physiological data with another user’s or the team’s physiological and environmental/chemical/biological data (e.g., [0015]., [0052] [0059]-[0060], [0116], [0119], [0138], [0148]-[0151], [0162]-[0164], [0185] of Radovcic; e.g., [0022], [0053] of Stone) (as recited in claim 19); wherein mother and baby behavioral/physiological data is inputted to the wearable device(s) via voice or touch input and/or collection via a sensor; the individual data is then processed and integrated together as well as individually being sent to a data correlation/trending module for analysis; the baby and mother can each have their own data correlation/trending module for analysis using machine learning (ML) which generates specific, individual observed relationship and suggested behavioral change information; the integrated data also undergoes analysis through a separate data correlation and trending module, using machine learning (ML); and the correlated/trending integrated data as well as the observed relationship and suggested behavioral changes for both the mother and baby are finally combined into an observed mother/baby relationship and suggested behavioral changes output (e.g., [0015]., [0052] [0059]-[0060], [0116], [0119], [0138], [0148]-[0151], [0162]-[0164], [0185] of Radovcic; e.g., [0022], [0053] of Stone) (as recited in claim 20); wherein the wearable device of the present invention supports multiple users with integrated data collection wherein a baby’s data from mom’s watch/account will be integrated with baby’s data from dad’s watch/account; a user can view the history of an event by pushing an icon on the watch screen or using a voice command.; and the user can input, through voice or touch, data throughout the day (e.g., [0015]., [0052] [0059]-[0060], [0116], [0119], [0138], [0148]-[0151], [0162]-[0164], [0185] of Radovcic; e.g., [0022], [0053] of Stone) (as recited in claim 21);wherein the backend of the wearable device will compute and record the event details with the date/ time it occurred and duration; a duration timer can be set to alert the user of the next event; there’s an option to input details during each event occurrence; there’s a calendar for reminders; there’s a notepad for notes about milestones and other information; an algorithm will generate suggestive care based on event history; data can be exported in table or graph form to an email, text, and cloud drive; and messaging between users (individually, group, and community chat) is supported (e.g., [0015]., [0052] [0059]-[0060], [0116], [0119], [0138], [0148]-[0151], [0162]-[0164], [0185] of Radovcic; e.g., [0022], [0053] of Stone) (as recited in claim 22); wherein first and second user behavioral/physiological data is inputted to the wearable device(s) via voice or touch input and/or collection via a sensor; the individual data is then processed and integrated together as well as individually being sent to a data correlation/trending module for analysis; the baby and mother can each have their own data correlation/trending module for analysis using machine learning (ML) which generates specific, individual observed relationship and suggested behavioral change information; the integrated data also undergoes analysis through a separate data correlation and trending module, using machine learning (ML); and the correlated/trending integrated data as well as the observed relationship and suggested behavioral changes for both the mother and baby are finally combined into an observed relationship and suggested behavioral changes output between the users (e.g., [0015]., [0052] [0059]-[0060], [0116], [0119], [0138], [0148]-[0151], [0162]-[0164], [0185] of Radovcic; e.g., [0022], [0053] of Stone) (as recited in claim 23); wherein an alarm can be set for a specified time; the user can monitor her health throughout the day by setting an alarm to remind them; and the user can also record their vitals at a random time (e.g., [0015]., [0052] [0059]-[0060], [0116], [0119], [0138], [0148]-[0151], [0162]-[0164], [0185] of Radovcic; e.g., [0022], [0053] of Stone) (as recited in claim 24) in order to improve outcomes.
Prior Art of Record
The prior art made of record and not relied upon is considered to be pertinent to applicant's disclosure.
The closest prior art is D. Ryu, D.H. Kim, J.T. Price, J.Y. Lee, H.U. Chung, E. Allen, J.R. Walter, H. Jeong, J. Cao, E. Kulikova, H. Abu-Zayed, R. Lee, K.L. Martell, M. Zhang, B.R. Kampmeier, M. Hill, J. Lee, E. Kim, Y. Park, H. Jang, H. Arafa, C. Liu, M. Chisembele, B. Vwalika, N. Sindano, M.B. Spelke, A.S. Paller, A. Premkumar, W.A. Grobman, J.S.A. Stringer, J.A. Rogers, & S. Xu, Comprehensive pregnancy monitoring with a network of wireless, soft, and flexible sensors in high- and low-resource health settings, Proc. Natl. Acad. Sci. U.S.A. 118 (20) e2100466118, (2021) (hereinafter “Ryu”).
Ryu teaches a wearable device that tracks and analyzes data for the mother–fetus dyad to care for both the fetus and mother during the antepartum/intrapartum period. However, Ryu does not teach or suggest a wearable device that tracks and analyzes data for the mother–infant dyad to care for both infant and mother during the postpartum and postnatal period. Note that, even though the authors say that their device is “applicable across the continuum of antepartum and postpartum care,” their device is applicable for use for postnatal care (of the infant, rather than the fetus).
The instant invention bridges two areas of innovation—wearable devices for postpartum care and wearable devices for postnatal care—in a way that gains significant advantages. By analyzing biometric data from the mother and the infant, correlating the two datasets and updating models with data synthesized thusly, the invention can arrive at insights that elude analyses of either one or the other dataset taken in isolation. The circular updating of the machine-learning model and the specific input modalities (e.g., microphone) well-suited for the postpartum/postnatal context are additional features recited in the claims that integrate the abstract idea (i.e., the mental process of tracking, predicting, suggesting, documenting, etc.) into a practical application.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.
For these reasons the claims are believed to be allowable over the art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT T LUAN whose telephone number is (571)270-1860. The examiner can normally be reached on 9am-5pm, M-F (generally).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Jackson, can be reached on 571-272-4697. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Scott Luan, Ph.D.
/SCOTT LUAN/Primary Examiner, Art Unit 3792