DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s amendments merit new grounds for rejection under 35 U.S.C. §§ 112(d) and 103 in view of Hafezi et al. (U.S. Patent Application Publication No. 2020/0121241); and Fernstrom et al. (U.S. Patent Application Publication No. 2009/0012433).
With respect to the rejections under 35 U.S.C. § 101, Applicant's arguments filed 8/6/2026 have been fully considered but they are not persuasive.
On p. 8 of the Remarks, Applicant argues that claims 1 and 11 as not being directed to an abstract idea and characterizes the claims as providing a practical application of the identified abstract idea by including “smart insight suggestion” on a display that is generated based on the determined “volume of milk consumed in real time”.
From MPEP § 2106.04(d), exemplary limitations the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:
An improvement in the functioning of a computer, or an improvement to other technology or technical field,
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition,
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim,
Effecting a transformation or reduction of a particular article to a different state or thing,
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception
Applicant’s claims do not appear to comprise any limitations that improve the functioning of a computer, effect a particular treatment or prophylaxis, implement the judicial exception with a particular machine that is integral to the claim, effect a transformation, or applying or using the judicial exception beyond generally linking the use of the judicial exception to a particular technological environment.
Specifically, monitoring a breastfeeding infant’s milk consumption and adjusting or receiving feedback in the form of smart insight recommendations appears to reflect the routine activities in lactation consultations. Applicant’s reliance upon a display, mobile device, processing, and sensors only generally link this abstract idea to the technological environment of sensors and a mobile device, and do not appear to render the claims eligible by providing a practical application.
With respect to the rejections under 35 U.S.C. § 103, Applicant's arguments are solely directed to whether the Chung reference teaches “comparing accelerometer data with microphone data to validate detection of a suckle or swallowing sound.” These arguments are considered unpersuasive in light of the new grounds for rejection below, and the following teachings from Fernstrom:
The Fernstrom reference teaches a system comprising a microphone and accelerometer together (¶[0022], ¶[0087]), which compares accelerometer data with microphone sensor data in the received sensor data to validate detection of a sound of a swallow, based on the accelerometer data indicating movement information for the sensor device at a same time that the microphone sensor data detects the sound (¶[0063], ¶[0113]), and a housing containing all of the sensors and processor (¶[0053]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the microphone or accelerometer of Nakar as modified to use both for simultaneous data collection and confirmation of swallows, as taught by Fernstrom, because Fernstrom teaches combining an accelerometer and microphone provides high pattern recognition ability and measurement accuracy (Fernstrom ¶[0089]). Further, it would have been obvious to co-locate the sensors in a housing, as taught by Fernstrom, because Fernstrom teaches improved acoustic coupling from attachment to the skin (Fernstrom, ¶[0081]) and desirable aesthetic features (Fernstrom ¶[0055]).
Claim Objections
Claim 11 is objected to because of the following informalities: the claim includes a typographical error “int eh” instead of “in the”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 9, the claim limitation “wherein the at least one sensor includes an accelerometer and a microphone” claims only that which is already claimed in claim 1 and therefore fails to further limit the claims. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 3, 7-9, 11, 13, 16, and 18-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
This analysis in view of 35 U.S.C. § 101 is based on MPEP § 2106, please see
this section of the MPEP for additional information.
First, the broadest reasonable interpretation of the claim as a whole is
established:
Claims 1 and 11 are directed to systems including a processor, sensor comprising accelerometer and microphone and a housing, mobile device, (and server in claim 14) where the system transmits data to a mobile device, which identifies child suckling and child swallowing sounds in a frequency range of 800Hz-1300Hz, validates the swallowing events by comparing accelerometer and sound data, calculates a volume of milk consumed dependent on the number of detected swallows, and provides recommendations via a display.
Step 1 of the analysis is the question: “Is the claim to a process, machine,
manufacture, or composition of matter?” and the answer is determined to be yes, as the
claims as a whole are directed to a manufacture and a method.
For Step 2, the preliminary question is whether the eligibility of the claim is self-
evident. The answer is determined to be no, as the claim is not immediately self-evident
as statutory.
Step 2A Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea?
A claim is directed to a judicial exception when a law of nature, a natural
phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim.
While the terms “set forth” and “describe” are thus both equated with “recite”, their
different language is intended to indicate that there are different ways in which an
exception can be recited in a claim. For instance, the claims in Diehr set forth a
mathematical equation in the repetitively calculating step, the claims in Mayo set forth
laws of nature in the wherein clause, meaning that the claims in those cases contained
discrete claim language that was identifiable as a judicial exception. The claims in Alice
Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.”
Claim 1 (and equivalently in claim 11) recites the following limitations:
identifies one or more portions of the sensor data as being a sound within a range between 800Hz and 1300Hz
determines a number of identifications of one or more portions of the sensor data being a sound within the range of 800Hz to 1300Hz
compares accelerometer data with microphone sensor data in the received sensor data to validate detection of an ambient sound within the range between 800Hz and 1300Hz based on the accelerometer data indicating movement information for the sensor device at the same time that the microphone sensor data detects the ambient sound within the range between 800Hz and 1300Hz
determines, using the number of identifications of one or more portions of the sensor data being a sound within the range of 800Hz to 1300Hz and data indicating movement information for the sensor device, a volume of milk consumed in real time.
The above identified elements comprise an explicit claim recitation of an abstract idea. Therefore, rather than merely involve a judicial exception, the claims are directed to the identified judicial exception.
This claim language is identified as an abstract idea, because in MPEP §
2106.04(a)(2) III B. this language is similar to concepts relating to organizing or
analyzing information in a way that can be performed mentally or are analogous to
human mental work. For example, Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d
1138, 120 USPQ2d 1473 (Fed. Cir. 2016). In Synopsys, the patentee claimed methods
of logic circuit design, comprising converting a functional description of a level sensitive
latch into a hardware component description of the latch. 839 F.3d at 1140; 120 USPQ2d at 1475. Although the patentee argued that the claims were intended to be
used in conjunction with computer-based design tools, the claims did not include any
limitations requiring computer implementation of the methods and thus do not involve
the use of a computer in any way. 839 F.3d at 1145; 120 USPQ2d at 1478-79. The
court therefore concluded that the claims “read on an individual performing the claimed
steps mentally or with pencil and paper,” and were directed to a mental process of
“translating a functional description of a logic circuit into a hardware component
description of the logic circuit.” 839 F.3d at 1149-50; 120 USPQ2d at 1482-83.
In the instant case, the identified abstract idea is similar to Synopsys because the
language reads on an individual performing the identification of suckling and swallowing sounds mentally or with a pencil and paper. They do not require any computer implementation that relies specifically upon computer technology and therefore are directed to a mental process of determining areas of a signal that comprise child suckling and child swallowing sounds through observation of sensor signal and analytical decision-making, manually calculating a volume of milk consumed based on the detected swallows, and coaching a nursing mother on improved nursing techniques, as a lactation consultant.
Yes. The claim is directed to an abstract idea.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
First, the additional elements are identified.
In claims 1-3, 7-13, 16, and 18-20: sensor comprising accelerometer and microphone, processor, mobile device, wireless transmission, server, display of suggestions.
The sensor, comprising processor, accelerometer, and microphone, is only nominally tied to the abstract idea and the data acquisition is all performed as pre-solution activity to the abstract idea claimed. Therefore the claimed sensor amounts to mere data gathering and considered an insignificant extra-solution activity.
The processor, mobile device, display, wireless transmission and server appear together to comprise an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter. The server is performing only generic computer functions and not, for example, performing any functions particular to serving data.
Display of “smart insight recommendations” is equivalent to mere output or display, and does not provide a particular treatment or prophylaxis. To the extent that the generally claimed “recommendations” can be considered particular, they are not provided as a treatment but rather as optional recommendations that a user may choose to perform or not to perform, and therefore do not comprise a particular treatment.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
The additional elements were identified in the above section under Step 2A Prong Two.
The sensor, comprising processor and microphone, is only nominally tied to the abstract idea and the data acquisition is all performed as pre-solution activity to the abstract idea claimed. Therefore the claimed sensor amounts to mere data gathering and considered an insignificant extra-solution activity.
The sensor, comprising processor, accelerometer, and microphone, is only nominally tied to the abstract idea and the data acquisition is all performed as pre-solution activity to the abstract idea claimed. Therefore the claimed sensor amounts to mere data gathering and considered an insignificant extra-solution activity.
The processor, mobile device, display, wireless transmission and server appear together to comprise an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter. The server is performing only generic computer functions and not, for example, performing any functions particular to serving data.
Display of “smart insight recommendations” is equivalent to mere output or display, and does not provide a particular treatment or prophylaxis. To the extent that the generally claimed “recommendations” can be considered particular, they are not provided as a treatment but rather as optional recommendations that a user may choose to perform or not to perform, and therefore do not comprise a particular treatment.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
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.
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(s) 1, 3, 7-9, 11, 13, 16, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakar et al. (WO 2015/040610) hereinafter referred to as Nakar; in view of Hafezi et al. (U.S. Patent Application Publication No. 2020/0121241) hereinafter referred to as Hafezi; in view of Fernstrom et al. (U.S. Patent Application Publication No. 2009/0012433) hereinafter referred to as Fernstrom; in view of Lagos et al. (Lagos HN, Santos RS, Abdulmassih EM, Gallinea LF, Langone M. Characterization of swallowing sounds with the use of sonar Doppler in full-term and preterm newborns. Int Arch Otorhinolaryngol. 2013 Oct;17(4):383-6.) hereinafter referred to as Lagos.
Regarding claims 1 and 11, Nakar teaches a system, comprising:
a sensor device to detect ambient noise around the sensor device (Fig. 4, element 400), and
a mobile device (Fig. 5, element 500, p. 20, lines 6-8), and
a server device (p. 22, lines 1),
wherein the mobile device:
wirelessly receives sensor data obtained by the sensor device (p. 21, lines 25-30, line 32), from an accelerometer or a microphone (Fig. 3, sensor 302 is a microphone, p. 16, lines 25-30), and the server device wirelessly receives sensor data from the mobile device (Nakar teaches that the data may be sent to a server and that the server or the mobile device may perform all of the following claimed functions p. 21, lines 30-end and p. 22 line 1, p. 23, lines 3-9).
identifies one or more portions of the sensor data as being a sound within a range (p. 13, lines 21-27; p. 11, lines 16-19),
determines a number of identifications of one or more portions of the sensor data being a sound in the ambient environment of the sensor device occurring within the range (p. 1, lines 5-7, Fig. 1, p. 13, lines 21-27; p. 11, lines 16-19, p. 18, lines 9-25 the signal analyzed is the audio signal, the algorithm identifies peaks in the audio signal and analyzes the temporal patterns around the peaks to determine swallow events, Fig. 2),
determines, using the number of identifications of one or more portions of the sensor data being a sound within the range, a volume of milk consumed in real time (p. 2, lines 16-20 number of detected infant swallowing events per feeding session; p. 15, lines 24-32 and p. 16, lines 5-10, p. 18, lines 1-6; real time in p. 20, lines 27-30, Nakar teaches determining volume of milk consumed based on number of detected swallows, but does not teach that the swallow itself is detected by both of sound and acceleration-this is taught in combination with Fernstrom below).
Nakar further teaches, a mother using data provided via a display in the mobile device to evaluate the determined volume of milk consumed, and determine adjustments to make to breastfeeding, in real-time, which constitutes an insight (p. 26, lines 6-21) but does not go so far as to teach providing one or more smart insight suggestions.
Nakar further does not teach a housing containing all of the sensors and processor, the detected sound being within a specific predetermined frequency range of 800Hz and 1300Hz for detecting swallows, or compares accelerometer data with microphone sensor data in the received sensor data to validate detection of a sound of a swallow, based on the accelerometer data indicating movement information for the sensor device at a same time that the microphone sensor data detects the sound.
Attention is drawn to the Hafezi reference, which teaches providing one or more smart insight suggestions (¶[0019] automated biofeedback and lactation coaching is considered smart insight suggestions) based on a sensor determination of volume of milk consumed by an infant during breastfeeding (Fig. 2C, graphical representation of volume of milk consumed, Fig. 11B ¶[0198], see claims 33-34).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the mother-driven manual insights of Nakar to include remote and automated lactation coaching, as taught by Hafezi, because Hafezi identifies coaching mothers on optimal nursing techniques based on calculation of breastmilk provided to a baby is an important advancement and particularly useful for the day to day nutrition of a baby (Hafezi ¶¶[0010-0012]).
Nakar as modified does not teach a housing containing all of the sensors and processor, the detected sound being within a specific predetermined frequency range of 800Hz and 1300Hz for detecting swallows, or compares accelerometer data with microphone sensor data in the received sensor data to validate detection of a sound of a swallow, based on the accelerometer data indicating movement information for the sensor device at a same time that the microphone sensor data detects the sound.
Attention is drawn to the Fernstrom reference, which teaches a system comprising a microphone and accelerometer together (¶[0022], ¶[0087]), which compares accelerometer data with microphone sensor data in the received sensor data to validate detection of a sound of a swallow, based on the accelerometer data indicating movement information for the sensor device at a same time that the microphone sensor data detects the sound (¶[0063], ¶[0113]), and a housing containing all of the sensors and processor (¶[0053]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the microphone or accelerometer of Nakar as modified to use both for simultaneous data collection and confirmation of swallows, as taught by Fernstrom, because Fernstrom teaches combining an accelerometer and microphone provides high pattern recognition ability and measurement accuracy (Fernstrom ¶[0089]). Further, it would have been obvious to co-locate the sensors in a housing, as taught by Fernstrom, because Fernstrom teaches improved acoustic coupling from attachment to the skin (Fernstrom, ¶[0081]) and desirable aesthetic features (Fernstrom ¶[0055]).
Nakar as modified does not teach the detected sound being within a specific predetermined frequency range of 800Hz and 1300Hz for detecting swallows.
Attention is drawn to the Lagos reference, which teaches neonate swallows occurring with peaks specifically in the predetermined frequency range of 800Hz and 1300Hz (Table 1-3).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the characteristic patterns in audio that Nakar as modified is analyzing to include specific peaks in the range of 800Hz-1300Hz, as taught by Lagos, because Lagos teaches that the mean initial frequency of swallow and second peak of swallow are 850Hz and 1087Hz, respectively, and precisely detecting the swallowing process is important scientifically and clinically (Lagos, p. 395, § Discussion ¶ 1).
Regarding claim 3, Nakar as modified teaches the system of claim 1.
Nakar further teaches wherein the processor receives sensor data from the microphone and transmits the received sensor data to the mobile device (Fig. 3, sensor 302 and processor 310; p. 21, lines 25-30, line 32).
Regarding claim 7, Nakar as modified teaches the system of claim 1.
Nakar further teaches wherein the mobile device calculates a volume of milk ingested by multiplying a constant per-swallow volume by a number of identified suckling and swallowing sounds during the predetermined time (p. 18, lines 1-6).
Regarding claim 8, Nakar as modified teaches the system of claim 7.
Nakar further teaches wherein the mobile device displays one or more of a real time volume of swallowed milk and a volume of swallowed milk per feeding session (p. 20, lines 27-30).
Regarding claim 9, Nakar as modified teaches the system of claim 1.
Fernstrom further teaches wherein the at least one sensor includes an accelerometer and a microphone (¶[0022], ¶[0087]).
Regarding claims 13, 16, 18-19, the claims are directed to substantially the same subject matter as claims 3, 7-9 and are rejected under substantially the same sections of Nakar, Hafezi, Fernstrom, and Lagos.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
